News Archive of FDA News - Business Wire

Acorda to Present at the Cowen and Company 37th Annual Healthcare Conference02-27-17
BTG Receives U.S. FDA 510(k) Clearance for EKOS® Control Unit 4.002-27-17
CureDuchenne Ventures Invests in New Gene Editing Company Exonics Therapeutics to Advance CRISPR/Cas9 Therapy for Duchenne Muscular Dystrophy02-27-17
Bristol-Myers Squibb to Take Part in Cowen and Company 37th Annual Global Health Care Conference02-27-17
AV Medical's Chameleon? Receives Expanded Indication to Include Infusion of Diagnostic or Therapeutic Fluids02-27-17
Wenzel Spine Announces FDA Clearance02-11-16
CreakyJoints Response to Advertisement Controversy02-11-16
Genetic Screening for Women's Cancer Risk May Be Reduced to $200 If Tested with Pap Smear02-11-16
Navidea Biopharmaceuticals Enrolls First Patient in Cervical Cancer Study of Lymphoseek®02-11-16
Teva Files 2015 Annual Report on Form 20-F02-11-16
Meeting the Needs of Ophthalmologists: ZEISS Showcases Integrated Solutions that Deliver Faster Practice and Surgical Workflow and Address Critical Diagnostic Challenges04-18-15
Full Data on Baxter's Investigational Recombinant Treatment BAX 111 Supports Potential Role to Treat von Willebrand Disease04-17-15
Pernix Therapeutics Inc. to Report First Quarter 2015 Financial Results04-17-15
FDA Approves Only ICD with Ultra-High Energy on the First Shock04-17-15
TransEnterix Announces Completion of GLP Studies04-16-15
Transgene SA: Agreement with FDA Announced for Special Protocol Assessment for Upcoming Phase 3 Pexa-Vec Trial in Advanced Liver Cancer04-16-15
Transgene SA : La future phase 3 de Pexa-Vec dans le cancer avancé du foie vient de recevoir l?accord de la Food and Drug Administration américaine pour une procédure spéciale de revue du protocole04-16-15
Research and Markets: FDA's New Import Program Concerning International Consequences: 9th, 10th of July 2015, San Francisco04-16-15
PsiOxus Therapeutics Expands Clinical Studies for Immuno-Oncolytic Treatment Following Positive Response to Intravenous Delivery04-16-15
Baxter Submits Application to Japan's MHLW for Approval of BAX 855, Extended Half-Life Recombinant FVIII Based on ADVATE for Hemophilia A04-16-15
Aradigm to Host Key Opinion Leader Breakfast and Webcast on April 23 in New York City04-16-15
FDA Advisory Committee Recommends Approval of The Medicines Company's Antiplatelet Therapy Cangrelor04-15-15
Provectus Biopharmaceuticals Opens Patient Enrollment; Begins Phase 3 International FDA Comparative Clinical Trial of PV-10 for Melanoma04-15-15
Bard Declares Quarterly Dividend04-15-15
CIO Review Names Paragon Solutions for 20 Most Promising Pharma and Life Sciences Consulting Providers04-15-15
Ophthalmology-focused CROs, Iris Pharma and Oculos Clinical Research Announce Strategic Alliance to Offer International Specialized Services to the Ophthalmic Market04-15-15
Avant Diagnostics, Inc. Begins OvaDx FDA Trials and Engages Clinical Research Organization04-15-15
Macrophage Therapeutics Announces Manocept? Results in Kaposi's Sarcoma Studies to Be Presented at the American Association of Cancer Research (AACR)04-15-15
The Medicines Company Stock Trading Halted Today04-15-15
Akebia Therapeutics Announces Proposed Public Offering of Common Stock04-14-15
Biogen Presents New Anti-LINGO-1 Phase 2 Acute Optic Neuritis Data Demonstrating Neurological Repair04-14-15
Conventus Orthopaedics Receives FDA Clearance for PH Cage?, Proximal Humerus Implant Device04-14-15
Sunovion Pharmaceuticals Inc. to Present Data on Aptiom® (eslicarbazepine acetate) at 67th American Academy of Neurology Annual Meeting04-14-15
Teva and Eagle Pharmaceuticals Announce NDA for Bendamustine Rapid Infusion Product Accepted for Filing04-14-15
MetaStat CEO Oscar L. Bronsther, M.D. to Participate in Moffitt Cancer Center's 9th Annual Business of Biotech Conference in Tampa on April 1704-14-15
Helius Medical Technologies to Start Its Registrational Clinical Trial04-13-15
Genzyme to Present New Long-Term Data on Aubagio® (teriflunomide) and Lemtrada® (alemtuzumab) at AAN04-13-15
ARCA biopharma Receives FDA Fast Track Designation for Gencaro? Atrial Fibrillation Development in a Genetically Targeted Heart Failure Population04-13-15
Critical Path Institute Secures Regulatory Support for Skeletal Muscle Safety Biomarkers04-13-15
Arrowhead Cleared to Proceed with Multiple Dose Phase 2b Study of ARC-52004-13-15
New Book by Industry Thought Leaders Advocates for Re-Engineering Clinical Trials04-13-15
Clinipace Worldwide Expands European Operations with Acquisition of Accovion04-13-15
CardiAQ? Valve Technologies Receives FDA IDE Approval for a US Early Feasibility Study of Its Second-Generation Transfemoral and Transapical Transcatheter Mitral Valve Implantation Systems04-10-15
Embera NeuroTherapeutics Secures A-2 Financing to Advance EMB-001 for Addictions Through Phase 1 Clinical Trial04-10-15
Exelixis? Cabozantinib Granted Fast Track Designation by FDA For Advanced Renal Cell Carcinoma04-09-15
Direct Flow Medical®, Inc. Announces FDA Approval to Broaden SALUS U.S. Pivotal Trial04-09-15
MEDI8897 Receives Fast Track Designation by the FDA for the Prevention of Respiratory Disease Caused by RSV in Infants04-09-15
MetaStat Discussed in Medscape and Other News Outlets04-09-15
AtriCure to Announce First Quarter 2015 Financial Results04-08-15
Anika Therapeutics Files IDE Application with U.S. FDA for Hyalofast®04-08-15
Iroko Pharmaceuticals Gains Additional Patents for ZORVOLEX® and TIVORBEX?04-08-15
SCIEX Launches P/ACE? MDQ Plus Capillary Electrophoresis System04-08-15
Grazoprevir/Elbasvir, Merck's Investigational Chronic Hepatitis C Therapy, Granted FDA Breakthrough Therapy Designations; New Phase 2 and 3 Data in Multiple HCV Patient Types to be Presented at The International Liver CongressTM 201504-08-15
Provectus Biopharmaceuticals to Present at 7th Annual International Partnering Conference, ChinaBio Partnering Forum 2015, Shanghai, China04-08-15
Dr. Reddy's Laboratories and Its Subsidiary Promius PharmaTM Announce the Filing of Three NDAs With the USFDA04-08-15
Provision First Proton Therapy Center Using New Product to Benefit Prostate Cancer Patients04-07-15
Big Data, Social Media and Patient Engagement Keynotes Reflect Dramatic Changes in Clinical Research at PCT 201504-07-15
Marina Plastic Surgery Offers Breakthrough Cellulite Treatment Cellfina04-07-15
One Lambda, Inc. Announces the Availability of the Only FDA Cleared IVD Test for Detecting HNA-304-07-15
Agendia Announces Recommendation of MammaPrint in Germany's AGO Guidelines, at St. Gallen International Breast Cancer Conference04-07-15
AATS Graham Foundation and AtriCure Announce James L. Cox Fellowship in Atrial Fibrillation Surgery04-07-15
Cytori Granted Orphan Drug Status for Cellular Therapeutic in European Union04-07-15
Lannett to Present at the 14th Annual Needham Healthcare Conference on April 14th04-07-15
Biogen Data at AAN Annual Meeting Underscore Commitment to Advancing Patient Care in Neurology04-07-15
MetaStat Appoints Martin J. Driscoll to Board of Directors04-07-15
Provectus Biopharmaceuticals? Data on PV-10 to Be Presented at HemOnc Today Melanoma and Cutaneous Malignancies Annual Meeting04-07-15
Mintz Levin Bolsters FDA Capabilities with Addition of Joanne S. Hawana04-06-15
Kathrin U. Jansen, Ph.D., to Lead Pfizer's Vaccine Research and Development Unit04-06-15
Regulatory Agencies in Asia and the U.S. Purchase Multiple Licenses of Simulations Plus Software04-06-15
Compugen to Present at Two Immuno-Oncology Conferences in April04-06-15
Bruker Announces FDA Clearance for Second, Expanded Claim for the MALDI Biotyper CA System04-03-15
The Medicines Company reçoit l?approbation de la Commission européenne pour trois produits de soins hospitaliers actifs : KENGREXAL? (cangrelor), ORBACTIV® (oritavancine) et RAPLIXA? (poudre hémostatique)04-03-15
Augmenix Announces FDA Clearance of SpaceOAR® System04-02-15
Perosphere Receives FDA Fast Track Designation for Investigational Anticoagulant Reversal Agent PER97704-02-15
U.S. FDA Grants Expanded Labeling Claim to On-X Life Technologies, Reducing Blood-Thinning Requirements for Heart Valve Patients04-02-15
Heron Therapeutics Reaches Target Patient Enrollment in MAGIC Phase 3 Study of SUSTOL®04-02-15
Bard to Host Earnings Conference Call on April 23, 201504-01-15
NEC Display Solutions Receives FDA 510(K) Clearance on MD322C8 Review Monitor04-01-15
LENSAR Receives FDA Clearance of Five New Performance Application Upgrades to the LENSAR Laser System04-01-15
Pelvalon Announces Clinical Data from Original Proof-of-Concept Study for Eclipse, the First Vaginal Device for Bowel Control04-01-15
Teva Announces FDA Approval of ProAir® RespiClick04-01-15
Samenvatting: Avedro ontvangt antwoord FDA op aanmelding nieuw product voor crosslinking04-01-15
Resumen: Avedro recibe carta completa de respuesta de la FDA sobre la solicitud de nuevo fármaco para el cross-linking corneal04-01-15
Avedro annonce la réception de la lettre de réponse complète de la FDA visant la soumission de la demande de nouveau médicament pour la réticulation cornéenne04-01-15
The Medicines Company ontvangt goedkeuring van de Europese Commissie voor drie producten voor acute zorg in ziekenhuizen: KENGREXAL? (cangrelor), ORBACTIV® (oritavancine) en RAPLIXA? (afdichtingspoeder).03-31-15
The Medicines Company riceve l'approvazione della Commissione europea per tre prodotti destinati alla terapia intensiva: KENGREXAL? (cangrelor), ORBACTIV® (oritavancin) e RAPLIXA? (adesivo tissutale in polvere)03-31-15
Riassunto: Avedro annuncia la ricezione di una lettera completa di risposta dalla FDA sulla richiesta di autorizzazione all'immissione in commercio per il cross-linking corneale03-31-15
Avedro meldet den Erhalt des vollständigen Antwortschreibens (Complete Response Letter) der FDA auf NDA für Hornhautquervernetzung03-31-15
Dyax Announces Positive Results from Phase 1b Clinical Trial of DX-293003-31-15
Avedro Announces Receipt of Complete Response Letter from FDA for Corneal Cross-Linking NDA03-31-15
Protalex Announces FDA Acceptance of Investigational New Drug Application for PRTX-100 to Treat Immune Thrombocytopenia03-31-15
OCuSOFT® HypoChlor? & the Facts about Hypochlorous Acid03-31-15
FDA's Mitch Zeller to Deliver Keynote Address at SFATA's May Conference03-31-15
ABMC Reports Fourth Quarter and Year End 2014 Results03-30-15
Europäische Kommission erteilt Zulassung für drei Produkte der Medicines Company zur Akutversorgung im Krankenhausumfeld: KENGREXAL? (Cangrelor), ORBACTIV® (Oritavancin) und RAPLIXA? (Pulverhämostatikum)03-30-15
The Medicines Company recibe aprobación de la Comisión Europea para tres productos de cuidados intensivos hospitalarios: KENGREXAL? (cangrelor), ORBACTIV® (oritavancina) y RAPLIXA? (polvo adhesivo)03-30-15
Genzyme's Cerdelga® (eliglustat) Capsules Approved in Japan03-30-15
OptiNose to Present at Innovations in Healthcare Executive Forum03-30-15
BRILINTA Receives US FDA Approval for New Administration Option03-30-15
GNC Reaches Agreement with New York Attorney General03-30-15
The Medicines Company Receives European Commission Approval for Three Hospital Acute Care Products: KENGREXAL? (cangrelor), ORBACTIV® (oritavancin) and RAPLIXA? (sealant powder)03-30-15
Biogen Announces EMA Validation of Marketing Authorization Application for SB2, a Biosimilar Candidate for Infliximab03-30-15
Langzeitdaten zu OTEZLA®(Apremilast) bei mittelschwerer bis schwerer Plaque-Psoriasis auf AAD-Jahrestagung vorgestellt03-27-15
Pharmacist's Letter Presents Interactive Session on the Evolving Role of Pharmacy Technicians at APhA03-27-15
NephroGenex Announces Data on Acute Kidney Injury at National Kidney Foundation 2015 Spring Clinical Meetings03-27-15
European Medicines Agency Validates Marketing Authorisation Application for ZINBRYTA? (Daclizumab High-Yield Process) for Treatment of MS03-27-15
Galderma Announces Positive Outcome of European Decentralised Procedure for Approval of SOOLANTRA® (ivermectin) Cream 10mg/g for Rosacea Patients03-27-15
Genzyme Convenes Sixth Annual Gaucher Leadership Forum03-26-15
The Health Management Academy Announces The Academy medCPU Center for Advanced Solutions in Healthcare03-26-15
Aduro Receives Orphan Drug Designation for CRS-207 in Mesothelioma03-26-15
pSivida Corp. Completes Targeted Enrollment of Phase III Trial of Medidur? for Posterior Uveitis03-26-15
OTEZLA® (apremilast) demuestra su eficacia y seguridad a largo plazo en pacientes con psoriasis en placas de moderada a grave03-26-15
ENCORE Clinical Data Published in The Lancet Suggest Treatment with Oral Maintenance Therapy Effective in Previously Treated Gaucher Disease Patients03-26-15
Guided Therapeutics Reports 2014 Results03-25-15
Therapeutic Research Center Debuts Hospital Prescriber's e-Letter03-25-15
MED Institute and FDA Sign Collaborative Research Agreement to Assess Radio Frequency Heating Safety of Passive Implants03-25-15
Navidea Biopharmaceuticals Announces Presentation of Lymphoseek® Data at Society of Surgical Oncology Meeting03-25-15
Therapure Innovations Receives FDA Approval to Proceed with a Phase 1 Clinical Trial of the Targeted Liver Cancer Therapeutic TBI 30203-25-15
Retrophin Closes Public Offering of 7,866,000 Shares of Common Stock and Full Exercise of Underwriters? Option to Purchase Additional Shares03-24-15
ACC Data Supports Mitralign Transcatheter Tricuspid Repair03-24-15
Kemwell announces successful USFDA inspection03-24-15
PierianDx Introduces PDx Score to Quickly Prioritize Actionable Variants, While Expanding Industry-Leading Knowledgebase03-24-15
Bristol-Myers Squibb Acquires Exclusive License from Novo Nordisk for a Discovery Research Program Focused on Autoimmune Diseases03-24-15
Biomedical Systems Announces Affiliation with the ePRO Consortium03-24-15
ARIAD and Medison Pharma Announce Approval of Iclusig (Ponatinib) in Israel03-24-15
Aerie Pharmaceuticals Completes Enrollment in Second Phase 3 Registration Trial (?Rocket 2?) of Rhopressa?, Novel Triple-Action Product to Lower Intraocular Pressure in Patients with Glaucoma03-24-15
Données de tolérance et d?efficacité à long terme d?OTEZLA® (apremilast), administré par voie orale chez les patients atteints de psoriasis en plaques chronique modéré à sévère, présentées lors de l?AAD03-24-15
Pfizer And Lilly Preparing To Resume Phase 3 Chronic Pain Program For Tanezumab03-23-15
NovaBone Products Receives 501(k) Clearance for Wound Dressing03-23-15
Kamada Awarded European Orphan Drug Designation for Its Alpha-1 Antitrypsin to Treat Graft-versus-Host Disease03-23-15
Biogen Idec Becomes Biogen03-23-15
Macrophage Therapeutics to Expand Efforts Into CNS Diseases03-20-15
Pfizer Announces Oral Tofacitinib Meets Primary Endpoints In Pivotal Phase 3 Psoriasis Trials03-20-15
Oral OTEZLA® (apremilast) Long-Term Safety and Efficacy Data in Patients with Moderate to Severe Plaque Psoriasis Presented at AAD03-20-15
Innate? Potato Receives FDA Safety Clearance03-20-15
Pernix Therapeutics Inc. to Present at the Deutsche Bank Pharma 1-on-1 Day in Denver, Colorado03-20-15
FDA Approves BIOTRONIK Eluna Pacemaker System with Full-Body ProMRI Technology03-20-15
Biogen Idec Presents Positive Interim Results from Phase 1B Study of Investigational Alzheimer's Disease Treatment Aducanumab (BIIB037) at 2015 AD/PD? Conference03-20-15
USDA Adds bioMérieux TEMPO® System to Microbiology Laboratory Guidebook, the Standard-Setting Guideline for Food-Safety Testing in the U.S.03-19-15
Galderma Announces Positive Phase 3 Trial Results of Investigational Adapalene 0.3%/Benzoyl Peroxide 2.5% (0.3% A/BPO) for the Treatment of Acne03-19-15
GlycoMimetics to Present First Preclinical Data on E-selectin-CXCR4 Dual Antagonist for Cancer Indications at AACR Annual Meeting 201503-19-15
Prestium Pharma, Inc. Announces Plans for Release of Improved OLUX® (Clobetasol Propionate) Foam03-19-15
Svelte Medical Systems Secures Financing; Richard Dakers Joins Board03-19-15
CanGaroo? de CorMatrix® Asegura la Aprobación Internacional para América del Sur03-19-15
CorMatrix® CanGaroo? Secures International Approval for South America03-18-15
Novan Achieves Target Enrollment for Phase 2 Acne Study03-18-15
AtriCure Launches Solution for Treatment of Post-Thoracotomy Pain03-18-15
PsychoGenics Obtains a License to ?-synuclein Transgenic Mouse Models of Parkinson´s disease03-18-15
Vertex Receives U.S. Food and Drug Administration Approval of KALYDECO® (ivacaftor) for Children with Cystic Fibrosis Ages 2 to 5 who have Specific Mutations in the CFTR Gene03-18-15
U.S. Food and Drug Administration Approves Cholbam for the Treatment of Rare Bile Acid Synthesis Disorders and Grants Rare Pediatric Disease Priority Review Voucher03-18-15
Etiometry Receives FDA 510(k) Clearance for its T3 Monitor03-18-15
Cynapsus Therapeutics Reports 2014 Annual Results03-17-15
InSite Vision Announces Settlement of Patent Infringement Lawsuit Against Mylan Pharmaceutical, Inc.03-17-15
Thorne Research Announces NSF Certification03-17-15
Aradigm Announces Fourth Quarter 2014 and Full Year Financial Results03-17-15
Jakavi® (ruxolitinib) Receives European Commission Approval as First Targeted Therapy for Patients with Polycythemia Vera03-17-15
Acorda Rings NASDAQ Opening Bell to Mark 20th Anniversary03-16-15
VuCOMP Announces FDA Approval of M-Vu® Computer-Aided Detection (CAD) for Mammography Version 3.203-16-15
Provectus Biopharmaceuticals? Amended Protocol of PV-10 for Phase 3 Study as Treatment for Melanoma Now Available Online03-16-15
ADC Therapeutics Submits its First IND For a Novel Antibody Drug Conjugate Against Lymphomas03-16-15
Cynapsus to Host Analyst and Investor Breakfast in New York City on March 1803-16-15
PEGASUS-TIMI 54 Study Shows That Long-Term Treatment with BRILINTA Reduced Thrombotic Cardiovascular Events in Patients with a History of Heart Attack03-14-15
Merck Provides Regulatory Update on Investigational Medicine Sugammadex Injection03-13-15
B. Smith & the Brain Health Registry Announce Partnership to Find Cures Faster for Alzheimer's Disease and All Brain Disorders03-13-15
Toshiba's Infinix 4DCT Receives FDA Clearance with Aquilion PRIME CT Configuration03-13-15
Anacor Pharmaceuticals Reports 2014 Fourth Quarter and Year-End Financial Results03-12-15
Bristol-Myers Squibb Announces Acceptance of New Drug Application for Investigational Daclatasvir for FDA Review for the Treatment of Hepatitis C Genotype 303-12-15
BIO Urges Governor Hickenlooper to Sign Bill That Ensures Patient Access to Interchangeable Biologic Medicines03-12-15
Allergen Research Corporation Completes $80 Million Series B Financing to Advance Drug Development Portfolio for Food Allergy03-12-15
Provectus Biopharmaceuticals Updates Market on Business Developments03-12-15
Provectus Biopharmaceuticals Awarded PH-10 Patent by U.S. Patent and Trademark Office03-12-15
Camargo Pharmaceutical Services Prepares for Growth, Names Jason Moore Vice President of Global Program Management03-12-15
Iroko Pharmaceuticals Announces Acceptance of U.S. Filing for SoluMatrix® Meloxicam in Osteoarthritis Pain03-12-15
Provectus Biopharmaceuticals, Inc. Reports Fourth Quarter and Year End 2014 Results03-12-15
Synta Reports Fourth Quarter and Year-End 2014 Financial Results03-12-15
Cynapsus Therapeutics Provides Clinical and Regulatory Update for APL-130277 for the Acute Rescue of OFF Motor Symptoms of Parkinson's Disease03-11-15
AtriCure Announces First Patient Enrolled in Stroke Feasibility Study05-21-14
Cardiovascular Systems to Feature Late-Breaking Coronary Data at SCAI 2014 Scientific Sessions05-21-14
DIA Executive Program Session to Examine Impact of Industry Shift to Targeted Therapies05-21-14
Cogmedix Selected to Manufacture Convergent Dental's Revolutionary CO2 Laser System05-21-14
Direct Flow Medical, Inc. Announces IDE Approval for U.S. Pivotal Trial05-21-14
Baxter Provides U.S. Regulatory Update on HyQvia, Its Investigational Subcutaneous Treatment for Primary Immunodeficiency05-21-14
Provectus Biopharmaceuticals Inc. Appoints Jacob M. Plotsker to Strategic Advisory Board05-21-14
Proa® Medical Receives 510(k) Clearance from FDA for Brella-Spec? Vaginal Speculum for Gynecological and Obstetrical Procedures05-20-14
PDS Releases First Publicly Available, FDA-Validated Dataset for SEND05-20-14
Navidea Announces Eleven Scientific Presentations of Results from Lymphoseek® and Manocept? Studies at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting05-20-14
FDA Grants QIDP Designation to Aradigm's Inhaled Antibiotic05-20-14
Amsel Medical Corporation Announces Filing of a 510(k) Pre-Marketing Notification with the US Food and Drug Administration for the Amsel Occluder Device05-20-14
Merck and Endocyte Announce Withdrawal of Conditional Marketing Authorization Applications for Vintafolide and Companion Imaging Components, Etarfolatide and Intravenous (IV) Folic Acid in Europe05-19-14
FDA International Regulators to Discuss Hurdles and Opportunities in Overseas Posts05-19-14
BioAlliance Pharma SA: Livatag® Receives Fast Track Designation From the FDA for the Treatment of Primary Liver Cancer05-19-14
BioAlliance Pharma SA : Livatag® obtient le statut « Fast Track » de la FDA pour le traitement du cancer primitif du foie05-19-14
Former FDA Senior Official - Dr. Rachel Sherman - Joins Greenleaf Health LLC05-19-14
Neos Therapeutics????????????ADHD??????????05-19-14
Neos Therapeutics????????????ADHD??????????05-19-14
DIA Annual Meeting Global Regulatory Track to Hold Town Halls05-19-14
Bristol-Myers Squibb and AbbVie Receive U.S. FDA Breakthrough Therapy Designation for Elotuzumab, an Investigational Humanized Monoclonal Antibody for Multiple Myeloma05-19-14
Recent Studies Further Demonstrate Astaxanthin's Potential as a Safe and Effective Anti-Inflammatory05-19-14
American Association of Clinical Endocrinologists Announces an Advanced Framework for a New Medically-Actionable Diagnosis of Obesity05-16-14
Pfizer To Submit Palbociclib New Drug Application With FDA Based On Final Results Of PALOMA-105-16-14
Neos Therapeutics?????ADHD????????????????????????????05-16-14
Samenvatting: Neos Therapeutics heeft patent op nieuwe ADHD-producten05-15-14
Neos Therapeutics Announces Issuance of New Patent Covering Composition of Matter for Company's Novel ADHD Products05-15-14
Neos Therapeutics kündigt neues Wirkstoffkombinationspatent für neuartige ADHS-Produkte an05-15-14
Neos Therapeutics annonce la délivrance d?un nouveau brevet couvrant la composition de matières pour les nouveaux produits THADA de la société05-15-14
Neos Therapeutics Anuncia la Emisión de una Nueva Patente que Cubre la Composición de Materia para Productos Nóveles para el ADHD de la Compañía05-15-14
Riassunto: Neos Therapeutics annuncia il rilascio di un nuovo brevetto relativo alla composizione di sostanze per i suoi nuovi prodotti anti ADHD05-15-14
Neos Therapeutics anuncia emissão de nova patente que abrange a composição de matéria para os novíssimos produtos ADHD da empresa05-15-14
Robotic Arm Approved by FDA, Identified by MD Buyline as an Emerging Technology05-15-14
BIO Urges Governor Markell to Sign Bill That Ensures Patient Access to Interchangeable Biologic Medicines05-15-14
Provectus Biopharmaceuticals? PV-10 Data Show Exceptional Complete Response Rates in Refractory Melanoma Patients05-14-14
Investigational PD-1 Immune Checkpoint Inhibitor Nivolumab Receives U.S. FDA Breakthrough Therapy Designation for Hodgkin Lymphoma05-14-14
Clovis Oncology Announces Clinical Data to Be Presented at 2014 ASCO Annual Meeting05-14-14
InVivo Therapeutics Announces Its Second Clinical Study Site for Neuro-Spinal Scaffold05-14-14
Guided Therapeutics Set to File Amended PMA Application for LuViva® Advanced Cervical Scan After ?Productive? Face-to-Face Meeting with FDA05-14-14
Proteon Therapeutics Announces Publication of Results from Phase 2 Study of PRT-20105-14-14
TKL Research Opens Research Clinic at the Fair Lawn Promenade05-14-14
Aradigm Announces First Quarter 2014 Financial Results05-14-14
Eagle Pharmaceuticals, Inc. Reports Second Quarter 2014 Results05-14-14
St. Jude Medical Announces First Implants in US Study of the Portico Transcatheter Aortic Heart Valve System05-13-14
Glytec Announces Late Breaking Abstracts Accepted for Poster Presentations at American Association of Clinical Endocrinologists 23rd Annual Scientific & Clinical Congress05-13-14
Ipsen Announces a Step Forward in the Resupply of Increlex® (Mecasermin [rDNA Origin] Injection) in the U.S.05-13-14
Lipella Pharmaceuticals Receives National Institutes of Health Funding for Its Orphan Drug Program05-13-14
Teva Announces FDA Acceptance of sNDA Filing for Pediatric Indication for QNASL® (Beclomethasone Dipropionate) Nasal Aerosol05-13-14
Ipsen Announces a Step Forward in the Resupply of Increlex® in the U.S.05-13-14
Ipsen annonce un premier réapprovisionnement d?Increlex® aux Etats-Unis05-13-14
ADMA Biologics Reports First Quarter 2014 Financial and Operational Results05-12-14
DIA 2014 50th Annual Meeting to Highlight TransCelerate BioPharma Collaboration05-12-14
Esaote Receives FDA Clearance for Virtual Navigator Ultrasound Fusion Imaging05-12-14
Park City Group Duo Address Quality Assurance Association05-12-14
Retrophin Initiates Global Access for RE-024 in Pantothenate Kinase-Associated Neurodegeneration (PKAN)05-12-14
FDA Approves ZONTIVITY? (vorapaxar), First-in-Class PAR-1 Antagonist, for the Reduction of Thrombotic Cardiovascular Events in Patients with a History of Heart Attack or with Peripheral Arterial Disease05-12-14
Richard A. Rudick Joins Biogen Idec as Vice President, Development Sciences, Value-Based Medicine05-12-14
Sorin Group Announces Freedom Solo FDA Study Results at the AATS 2014 Scientific Sessions05-12-14
Biogen Idec and Sobi to Donate 1 Billion International Units of Clotting Factor to Support Treatment of Hemophilia in Developing World05-12-14
Batu Biologics Files Patent Covering New Use of Approved Drug for Decreasing Cancer Immunotherapy Toxicity05-10-14
CHPA Files Comments to FDA Regarding OTC Monograph System05-09-14
Study Results Show Significant Overall Cost Savings with St. Jude Medical Quadripolar System05-09-14
Vestiage Announces Re-Branding05-09-14
Pacemaker and Defibrillator Patients Adhering to Remote Monitoring with St. Jude Medical's Merlin Technology Saw More than Double Survival Rate05-08-14
Circulatory System Devices Advisory Panel Provides Favorable Recommendation to FDA on Risk-Benefit Profile of ResQCPR System05-08-14
Genzyme and Isis Receive Corporate Award from the National Organization for Rare Disorders (NORD) for the Development of KYNAMRO®05-08-14
Baxter Receives 510(k) Clearance for Next-Generation SIGMA Spectrum Infusion Pump with Master Drug Library05-08-14
NPS Pharma Reports First-Quarter 2014 Financial Results05-08-14
Teva Announces COPAXONE® Recognized as ?Brand of the Year? by Pharmaceutical Executive Magazine05-08-14
St. Jude Medical Continues Its Quadripolar Technology Leadership at HRS 201405-08-14
Harvard Apparatus Regenerative Technology Reports Operating Results for First Quarter Ended March 31, 201405-08-14
Sarepta Therapeutics Announces First Quarter 2014 Financial Results and Recent Corporate Developments05-08-14
Agenus Reports First Quarter 2014 Financial Results05-08-14
PRIUM White Paper Highlights the Lack of Information on Tapering Opioids When Used With Other Drugs for Pain Management05-08-14
e-Therapeutics announces recruitment resumes into US phase I ETS2101 brain cancer trial05-08-14
FDA Approves BIOTRONIK Entovis Pacemaker System with ProMRI® Technology05-07-14
Corporate Action Network: Injured Women Call on Johnson & Johnson to Immediately Stop Producing Dangerous Pelvic Mesh Implants05-07-14
Netsmart Engaged in Public Policy Advocacy on Behalf of Behavioral Health and Human Services Providers05-07-14
ARIAD Reports First Quarter 2014 Financial Results and Development Progress05-07-14
Navidea Biopharmaceuticals Announces First Quarter 2014 Financial Results05-07-14
NanoString Technologies Receives Canadian Market Approval for its Prosigna Breast Cancer Prognostic Gene Signature Assay05-06-14
SynteractHCR Experts Speaking at Outsourcing in Clinical Trials U.S. and European Shows05-06-14
FDA Approves EPANOVA For the Treatment of Adults with Severe Hypertriglyceridemia05-06-14
Icon Bioscience Achieves Key Milestone with IBI-10090 Advancing Through Phase 3 Studies; Drug Targets Medical Need for Long-Acting Treatment of Inflammation Post Cataract Surgery05-06-14
Merck Announces FDA Acceptance for Review of MK-3475 Biologics License Application for Advanced Melanoma05-06-14
Antares Pharma Announces Update to QuickShot Testosterone Program05-06-14
Alnylam Advances Development Candidate for ALN-AAT, a Subcutaneously Administered RNAi Therapeutic Targeting Alpha-1 Antitrypsin (AAT) in Development for the Treatment of AAT Deficiency-Associated Liver Disease05-06-14
Actinium Announces Start of Collaboration to Manufacture IomabTM-B for Phase 3 Clinical Trial and Commercialization05-06-14
GHX Expands Unique Device Identification Solution with PTC05-06-14
Provectus Biopharmaceuticals Inc. Appoints Brendan O?Brien to Strategic Advisory Board05-06-14
Acorda Therapeutics Reports First Quarter 2014 Financial Results05-06-14
St. Jude Medical to Present at the Bank of America Merrill Lynch 2014 Health Care Conference05-05-14
GREER® Laboratories, Inc. Launches ORALAIR®, the First and Only Sublingual Allergy Immunotherapy Tablet with a Mix of Five Grass Allergens for the Treatment of Grass Pollen Allergy05-05-14
FDA Approves Teva's SYNRIBO® (Omacetaxine Mepesuccinate) for Injection for Home Administration05-05-14
FDA Approves Conversion of Soliris® (eculizumab) Accelerated Approval in aHUS to Regular Approval for the Treatment of Patients with aHUS05-05-14
Synageva BioPharma? Announces Satellite Symposium at the National Lipid Association Meeting05-02-14
FDA Issues Complete Response Letter for PLUMIAZ?, Investigational Medicine for Epilepsy Cluster Seizures05-02-14
Vertex Reports First Quarter 2014 Financial Results and Provides Updates on Key Business Priorities05-01-14
Alnylam to Webcast Conference Call Discussing First Quarter 2014 Financial Results05-01-14
American Regent's Injectafer® (Ferric Carboxymaltose Injection) Assigned Q Code by Centers for Medicare and Medicaid Services05-01-14
Synergy Pharmaceuticals to Present Data on SP-333 at Digestive Disease Week 201405-01-14
Alnylam Presents New Pre-clinical Data on Subcutaneously Delivered RNAi Therapeutics for Cardiovascular Metabolic Disease at Arteriosclerosis, Thrombosis and Vascular Biology 2014 Scientific Sessions05-01-14
FDA Commissioner Among Top Global Regulators Attending DIA Annual Meeting05-01-14
ALO-02 Demonstrates Significant Difference In Pain Scores In Chronic Low Back Pain Patients And Lower Abuse Potential Compared To Immediate-Release Oxycodone In Recreational Opioid Users05-01-14
diaDexus Announces Completion of Validation Cohort for the PLAC® Test for Lp-PLA2 Activity05-01-14
Specialty Vaccine Company PaxVax Selected to Present at Cavendish Global Health Impact Forum05-01-14
New TYSABRI® Analysis at AAN Annual Meeting Shows Improved Walking Speed in Significant Number of MS Patients05-01-14
Harvard Apparatus Regenerative Technology Schedules Release of First Quarter 2014 Financial Results and Investor Teleconference for May 8th05-01-14
Incyte Reports 2014 First-Quarter Financial Results and Updates Shareholders on Key Clinical Programs05-01-14
CytRx Reports 2014 First Quarter Financial Results05-01-14
Cardiovascular Systems Reports Fiscal 2014 Third-Quarter Financial Results04-30-14
FDA Clears GE's New Discovery IGS 740 Mobile Angiography System04-30-14
Genzyme Announces Multi-Year Multiple Sclerosis Research Collaboration with Leading Academic Medical Center04-30-14
Slowing of Brain Atrophy and Reductions in New Multiple Sclerosis Lesions Sustained at Three Years in Patients Treated with Genzyme's LemtradaTM04-30-14
Carestream's Newest Image Acquisition/Mini-PACS Software Receives FDA 510(k) Clearance for Viewing on iPad Mobile Devices04-30-14
Mallinckrodt Pharmaceuticals to Present New Clinical Data at American Pain Society Annual Scientific Meeting04-30-14
ArQule to Report First Quarter 2014 Financial Results on May 7, 201404-30-14
Ligand Partner GlaxoSmithKline Gains Priority Review Designation for Promacta?/Revolade? for Severe Aplastic Anemia04-30-14
New Data Reinforce Efficacy of TECFIDERA® (Dimethyl Fumarate) in MS Patients with High Disease Activity04-30-14
Braeburn Pharmaceuticals to Initiate New Clinical Study for Probuphine Following Clear Guidance from FDA04-30-14
Navidea Biopharmaceuticals to Announce First Quarter 2014 Financial Results on May 7, 201404-29-14
Clinical Trial Experts to Discuss Relationship Between ?Big Data? and Strategic CRO and Clinical Trial Sponsor Partnerships04-29-14
Eagle Pharmaceuticals to Present at 39th Annual Deutsche Bank Health Care Conference04-29-14
GE Healthcare Announces First U.S. Markets For New Alzheimer's Diagnostic Tool for Detection of Beta Amyloid04-29-14
Alnylam Presents New Pre-clinical Data on RNAi Therapeutics Targeting Transthyretin (TTR) for the Treatment of TTR-Mediated Amyloidosis (ATTR)04-29-14
Biogen Idec to Present New Two-Year Data from the PLEGRIDY? (Peginterferon Beta-1a) Phase 3 ADVANCE Study at AAN Annual Meeting04-29-14
Dendreon to Host Conference Call on May 8 to Announce First Quarter Financial Results04-28-14
Provectus Biopharmaceuticals, Inc. Retains Roberti+White, LLC as Public Policy Consultants04-28-14
Southern Illinois University School of Medicine Becomes Clinical Site for CEL-SCI's Global Phase III Immunotherapy Head and Neck Cancer Trial04-28-14
Civitas Therapeutics Announces Positive Phase 2b Results for CVT-301, Inhaled Levodopa for the Treatment of Parkinson's Disease04-28-14
Alnylam and Collaborators Present New Clinical Data for Patisiran, an RNAi Therapeutic Targeting Transthyretin (TTR) in Development for the Treatment of TTR-Mediated Amyloidosis (ATTR)04-28-14
Ocular Therapeutix to Present New Data on Sustained Release Drug Candidates Utilizing Proprietary Hydrogel Technology at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting04-28-14
pSivida Reports Australia/New Zealand Distribution Agreement for ILUVIEN® for DME04-28-14
Actinium Announces Key Additions to Senior Management Team04-28-14
Monarch Medical Technologies Launches New EndoTool IV? to Further Enhance Patient-Specific Glycemic Control in Hospitals04-28-14
CytRx to Present Completed Phase 1b/2 Progression-Free Survival and Overall Survival Aldoxorubicin Data in Second-Line Soft Tissue Sarcoma at Upcoming Research and Development Day04-28-14
POZEN's PA8140/PA32540 Receives a Complete Response Letter From FDA Citing Issues at a Facility of a Third Party Supplier of an Active Ingredient04-26-14
Statement by John Wiesehan Jr., CEO of Mistic Electronic Cigarettes, Regarding FDA's Proposed Deeming Regulations on E-Cig Category04-24-14
AtriCure Reports First Quarter 2014 Financial Results and Updates 2014 Outlook04-24-14
GenMark Diagnostics Schedules First Quarter 2014 Financial Results Conference Call for May 6, 201404-24-14
NJOY Welcomes Proposed FDA Regulations for Electronic Cigarettes04-24-14
Kamada Announces Significantly Improved Infusion Rate for Glassia®04-24-14
MD Buyline Provides Clinical Insight into the FDA Medical Device Recall Report04-24-14
GlycoMimetics Appoints Seasoned Business Development Executive Armand Girard as New Vice President, Corporate Development04-23-14
Baxter Announces FDA Approval of ADVATE (Antihemophilic Factor [Recombinant]) with BAXJECT III Reconstitution System04-23-14
Tolero Pharmaceuticals Receives FDA Orphan Drug Designation for Alvocidib for the Treatment of Acute Myeloid Leukemia04-23-14
Catalyst Announces Initiation of an Expanded Access Program to Provide Firdapse at No Cost to U.S. Patients with Lambert-Eaton Myasthenic Syndrome04-23-14
La Administración de Alimentos y Fármacos (FDA) de EE.UU. acepta solicitudes de nuevos fármacos para cobicistat y elvitegravir de Gilead Sciences para el tratamiento del VIH04-22-14
Conventus Orthopaedics, Inc. Secures $10 Million Credit Facility to Support Continued Growth04-22-14
DIA 2014 50th Annual Meeting to Offer Insight on Successfully Navigating the Human Stem Cell Regulatory Process04-22-14
Provectus PV-10 klinikiniai duomenys apie melanomos gydym? bus pristatyti 10-ajame Europos dermatoonkologijos asociacijos suva?iavime04-22-14
Enanta Pharmaceuticals Announces New Drug Application Submission to the U.S. FDA for All-Oral, Interferon-Free Hepatitis C Regimen04-22-14
Data from Genzyme's Multiple Sclerosis Franchise Featured at AAN04-22-14
Pfizer Announces Positive Top-Line Results from Two Phase 3 Trials of Tofacitinib in Adults with Moderate-to-Severe Chronic Plaque Psoriasis04-22-14
Emergent BioSolutions and FDA Finalize Comparability Protocols Enabling Manufacturing of BioThrax Consistency Lots in Building 5504-22-14
Les demandes déposées par Gilead Sciences d'autorisation des nouveaux médicaments pour Cobicistat et Elvitegravir pour le traitement du VIH sont acceptées par la FDA des États-Unis04-22-14
Anträge von Gilead Sciences auf Zulassung der neuen Medikamente Cobicistat und Elvitegravir zur HIV-Behandlung von der US-amerikanischen FDA akzeptiert04-22-14
Le domande di approvazione di un nuovo farmaco presentate nuovamente da Gilead Sciences per cobicistat ed elvitegravir quale terapia anti-HIV, sono state accettate dall?ente statunitense preposto al controllo dei farmaci e degli alimenti...04-22-14
Nieuwe geneesmiddelvergunningaanvragen van Gilead Sciences voor cobicistat en elvitegravir voor hiv-behandeling geaccepteerd door U.S. FDA04-22-14
Gilead Sciences? New Drug Applications for Cobicistat and Elvitegravir for HIV Therapy Accepted by U.S. FDA04-21-14
Cubist Announces Submission of New Drug Application for Investigational Antibiotic Ceftolozane/tazobactam04-21-14
HD Medical to Showcase ViScope Visual Stethoscope in Houston04-21-14
Emergent BioSolutions Receives Orphan Drug Designation for BioThrax for Post-Exposure Prophylaxis of Anthrax Disease04-21-14
Sarepta Therapeutics Announces Plans to Submit New Drug Application to FDA for Eteplirsen for the Treatment of Duchenne Muscular Dystrophy by Year End 201404-21-14
Provectus? PV-10 Clinical Data on the Treatment of Melanoma to Be Presented at 10th European Association of Dermato-Oncology Congress04-21-14
FDA Approves Merck's RAGWITEK? (Short Ragweed Pollen Allergen Extract) Sublingual Tablet as Immunotherapy to Treat Short Ragweed Pollen-Induced Allergic Rhinitis with or without Conjunctivitis in Adults04-17-14
Navidea Biopharmaceuticals Provides Progress Updates on Lymphoseek® Programs04-17-14
Drug-Exposure Limitations of Oral Methotrexate at Doses Greater Than or Equal to 15 Mg May Be Overcome with Subcutaneous Administration04-17-14
Intelligent Hospital Systems Acquired by Longtime Leading Shareholder Ed Van Humbeck and Family04-16-14
Harvard Apparatus Regenerative Technology Names Saverio La Francesca, MD as its Chief Medical Officer04-16-14
Convergent Dental, Inc. Secures $8 Million in Oversubscribed Funding Round04-16-14
Dr. Reddy's Announces the Launch of Eszopiclone Tablets C-IV04-16-14
PanOptica Raises $45 Million to Finance Clinical Development of Anti-VEGF Eye Drop for Wet AMD04-15-14
Akebia Therapeutics Announces Completion of Enrollment in its Phase 2b Clinical Study of AKB-654804-15-14
ASQ Quality and Safety Conference Features Food, Drug, Cosmetic Experts04-15-14
Orchid Orthopedic Solutions Selects CEBOS Quality Management System to Support Rapid Growth and Meet Compliance04-15-14
Lannett Receives FDA Approval for Diazepam Oral Solution (Concentrate), 5 mg/mL04-15-14
Results from Non-Tuberculous Mycobacteria (NTM) Study Using Aradigm's Liposomal Ciprofloxacin to be Presented at the American Thoracic Society 2014 International Conference04-15-14
Reverse Medical® Corporation Announces FDA IDE Approval for the BARREL® Vascular Reconstruction Device for the Treatment of Intracranial Bifurcation Aneurysms04-15-14
FDA Gives Clearance to Proceed with Clinical Study - New Drug Candidate from Vivolux Starves Cancer Cells04-15-14
FDA Approves Merck's GRASTEK® (Timothy Grass Pollen Allergen Extract) Sublingual Tablet as Immunotherapy to Treat Grass Pollen-Induced Allergic Rhinitis with or without Conjunctivitis in Children and Adults04-14-14
VuCOMP M-Vu® Breast Density Version 2.0 Released04-14-14
True North Therapeutics Publishes Study in Blood Demonstrating Ex Vivo Efficacy of a C1s Antibody in Cold Agglutinin Disease Patient Samples04-14-14
GlycoMimetics Announces Presentation of Data on Rivipansel (GMI-1070) in Combination with Current FDA-Approved Treatment for Sickle Cell Disease04-14-14
FDA-EMA Leadership to Discuss Pharmacovigilance at DIA Annual Meeting04-14-14
Bristol-Myers Squibb Submits New Drug Application to U.S. FDA for a Fixed-Dose Combination Tablet of Atazanavir Sulfate with Cobicistat for People Living with HIV-104-14-14
Covidien Announces U.S. Food and Drug Administration 510(k) Clearance for the Kangaroo? Feeding Tube with IRIS Technology04-14-14
Biogen Idec to Present New Clinical Data from Its Robust Neurology Portfolio at AAN Annual Meeting04-14-14
pSivida Announces September 26, 2014 PDUFA Date for ILUVIEN®04-14-14
Retrophin Updates Financial Guidance for 2014 and 2015 and Provides Corporate Update04-14-14
Research and Markets: Global Companion Diagnostics (CDx) Market 2013-201604-14-14
Ipsen announces a first set of results on positive phase III clinical study of Dysport® in the treatment of adults suffering from Upper Limb Spasticity at the 8th World Congress for NeuroRehabilitation in Istanbul04-12-14
Ipsen annonce des premiers résultats sur l?étude clinique positive de phase III avec Dysport® dans le traitement de la spasticité des membres supérieurs chez l?adulte à la 8ème Conférence Mondiale de Neuroréhabilitation à Istanbul04-12-14
Researchers to Present New Data on Asfotase Alfa in Infants and Juveniles with Hypophosphatasia at the Joint Meeting of the Pediatric Academic Societies and the Asian Society for Pediatric Research04-11-14
Covidien Implements Voluntary Recall of its Pipeline? Embolization Device and Alligator? Retrieval Device04-11-14
FzioMed Announces Date for Medical Device Dispute Resolution Panel on Oxiplex®04-11-14
Nexstim Selected as a 2014 Red Herring Top 100 Europe04-11-14
Leading CRO Chooses Instem Software Solutions for Global Multi-Site Deployment04-10-14
Guided Therapeutics Receives May 8th Meeting Date from FDA to Discuss LuViva® Advanced Cervical Scan PMA Application04-10-14
3D Implantable Marker Reported to Clearly Identify Surgical Area in Breast Cancer Patients04-10-14
Navidea Announces Presentation of Study Findings of Manocept? Platform Imaging Agent in Kaposi Sarcoma at AACR Annual Meeting04-10-14
Biogen Idec Names Adam M. Koppel as SVP and Chief Strategy Officer04-10-14
Biogen Idec and Sobi Announce Positive Top-Line Efficacy and Safety Results from Phase 3 Pediatric Study of Investigational Therapy Eloctate? (rFVIIIFc) for Hemophilia A04-10-14
Senator Pryor Honored as BIO Legislator of the Year04-09-14
Congressman Farr Honored as BIO Legislator of the Year04-09-14
NEC Display Solutions Receives FDA 510(k) Clearance on MD302C4 Diagnostic Review Monitor04-09-14
Palmetto Health Produces First IV Medications with RIVA Pharmacy Automation Technology04-09-14
Telcare Joins Verizon Partner Program, Offers Award-winning Diabetes Monitoring System04-09-14
GlycoMimetics Presents Data on Its E-Selectin Antagonist at American Association for Cancer Research Annual Meeting 201404-09-14
Forest Laboratories and Almirall Provide Update on the Fixed Dose Combination of Aclidinium and Formoterol in the U.S.04-09-14
Arizona's Long-Term Bioscience Plan Updated, Extended Through 202504-08-14
Gilead anuncia la designación de revisión prioritaria de la FDA de Estados Unidos para el comprimido de combinación de dosis fija de ledipasvir/sofosbuvir para la infección de la hepatitis C crónica de genotipo 104-08-14
First MAGEC® Surgery in the United States Completed04-08-14
Gilead annuncia la concessione da parte dell'ente statunitense preposto al controllo dei farmaci e degli alimenti (Food and Drug Administration, FDA) dello stato di revisione prioritaria per la terapia combinata a dosaggio fisso sotto (...).04-07-14
Once-Daily Aptiom® (eslicarbazepine acetate) for the Adjunctive Treatment of Partial-Onset Seizures Now Available in U.S. Pharmacies04-07-14
Gilead Announces U.S. FDA Priority Review Designation for Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Chronic Hepatitis C Genotype 1 Infection04-07-14
Gilead gibt Gewährung eines beschleunigten Prüfverfahrens der US-Arzneimittelbehörde FDA für Ledipasvir/Sofosbuvir Festdosis-Kombinationspräparat gegen chronische Hepatitis-C-Infektionen des Genotyps 1 bekannt04-07-14
Gilead annonce la désignation d?évaluation prioritaire de l?U.S. FDA pour le comprimé combiné à dose fixe ledipasvir/sofosbuvir pour l?infection à l?hépatite C chronique de génotype 104-07-14
Gilead kondigt Amerikaanse FDA Prioritair Overzicht-status voor Ledipasvir/Sofosbuvir combinatietablet met vaste dosis voor chronische genotype 1 hepatitis C-virusinfectie aan04-07-14
Calgary Scientific Receives FDA Clearance for Mobile Diagnosis on all Modalities04-07-14
Bristol-Myers Squibb Submits NDAs for Daclatasvir and Asunaprevir to US FDA for the Treatment of Hepatitis C04-07-14
Alnylam's McSwiggen Patent Upheld in European Opposition Proceedings04-07-14
Actinium Announces Further Development of Actimab-A Manufacturing04-07-14
Induction of Systemic Immunity Following Treatment of Tumors with PV-10 Reported by Moffitt Cancer Center Researchers at American Association for Cancer Research Annual Meeting04-07-14
Genzyme to Resubmit LemtradaTM Application for FDA Review04-07-14
AtriCure to Announce First Quarter 2014 Financial Results04-04-14
Health IT Now Coalition Applauds Release of FDASIA Report, Calls for Congressional Action04-04-14
Santen Phase III Study Meets Primary Endpoint for the Treatment of Non-Infectious Posterior Segment Uveitis (NI-PSU)04-04-14
World's First and Only Upgradeable Spinal Cord Stimulation System Receives FDA Approval04-04-14
Furiex Pharmaceuticals Announces Acceptance to Late-Breaking Abstract Session at Digestive Disease Week 201404-03-14
Dyax Receives FDA Approval to Expand Use of KALBITOR® (ecallantide) for the Treatment of Acute Attacks of Hereditary Angioedema to Patients 12 Years of Age and Older04-03-14
TapImmune Inc. is Pleased to Provide an Update on Corporate Events and Milestones for 201404-03-14
First Patients Implanted with ICDs in BIOTRONIK ProMRI® Study04-03-14
VeriTeQ Corporation to Sponsor and Present at 11th International Committee for Quality Assurance, Medical Technologies and Devices in Plastic Surgery Congress and Consensus Conference04-03-14
EnVivo Pharmaceuticals, Inc. wordt FORUM Pharmaceuticals Inc.04-02-14
Carestream's New Bone Suppression Software Receives FDA Clearance, Now Available Worldwide04-02-14
FDA Grants IND Approval for Phase IIa Clinical Trial Using CardioCell's itMSC Therapy to Treat Dilated Chronic Heart Failure04-02-14
ArQule, Inc. to Present at Needham 13th Annual Healthcare Conference04-02-14
EnVivo Pharmaceuticals, Inc. Becomes FORUM Pharmaceuticals Inc.04-02-14
Provectus Biopharmaceuticals? PV-10 Data to Feature in Poster Presentation by Moffitt Cancer Center at the American Society of Clinical Oncology (ASCO) Annual Meeting04-02-14
GREER® Laboratories, Inc. Announces FDA Approval of ORALAIR®, the First Sublingual Allergy Immunotherapy Tablet, for the Treatment of Grass Pollen Allergy04-01-14
VuCOMP's James Pike Expands Role04-01-14
VertiFlex®, Inc. Announces Submission of Final PMA Module to the FDA, for the Superion® Interspinous Spacer System04-01-14
Rotation Medical Receives 510(k) Clearance for Implantable Collagen Scaffold Technology for Treating Rotator Cuff Disease04-01-14
Cubist Appoints Robert J. Perez to Board of Directors04-01-14
Provectus Biopharmaceuticals? PV-10 Data to Be Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting04-01-14
Academy of Managed Care Pharmacy Conference Features Poster Presentations on Tapering Patients off Opioids and Benzodiazepines04-01-14
Provectus Biopharmaceuticals? PV-10 Data to Be Presented at the HemOnc Today Melanoma and Cutaneous Malignancies Conference04-01-14
FDA Advisory Committee Unanimously Recommends Approval of Cubist's SIVEXTRO? (Tedizolid Phosphate) as Treatment for Serious Skin Infections03-31-14
Teva Announces U.S. Supreme Court Will Hear Its Appeal on COPAXONE® Patent03-31-14
OPKO Announces Launch of 4Kscore Test for Prostate Cancer03-31-14
Oxygen Biotherapeutics Inc. Provides an Update on Communication with the FDA Regarding Oxycyte Development Program03-31-14
CytRx Receives Orphan Medicinal Product Designation from the European Commission for Aldoxorubicin in Soft Tissue Sarcoma03-31-14
rEVO Biologics Inc. Initiates PRESERVE-1 Phase 3 Clinical Trial for ATryn® in Early-Onset Preeclampsia03-31-14
Pacira Pharmaceuticals, Inc. Announces FDA Approval of Additional Manufacturing Suite for EXPAREL03-31-14
PHT Corporation Launches New App of FDA Roadmap to Patient-Focused Outcome Measurement in Clinical Trials for Android Phones and Tablets03-31-14
Forest Laboratories, Inc. and Gedeon Richter Plc. Announce Positive Phase IIb Topline Results for Cariprazine for the Treatment of Bipolar Depression03-31-14
PHT Corporation lance une nouvelle application de FDA Roadmap (feuille de route de la FDA) pour la mesure des résultats axés sur les patients lors d'essais cliniques, sur les téléphones et tablettes Android03-31-14
Die PHT Corporation erschließt mit neu eingeführter App für Android-Mobiltelefone und ?Tablets die FDA-Roadmap zur patientenorientierten Ergebnismessung in klinischen Studien03-31-14
FDA Approves Biogen Idec's ALPROLIX?, the First Hemophilia B Therapy to Reduce Bleeding Episodes with Prophylactic Infusions Starting at Least a Week Apart03-28-14
Exact Sciences Announces FDA Advisory Committee Unanimously Recommends Approval of Cologuard03-27-14
Meridian Bioscience Receives FDA Clearance for New Molecular Amplification Test: illumigene® Pertussis03-27-14
BIO Announces Kay Holcombe to Join as Senior Vice President, Science Policy03-27-14
Furiex Pharmaceuticals Confirms Takeda Will Present Additional Data from the EXAMINE Trial at the American College of Cardiology's 63rd Annual Scientific Session03-27-14
ZS Pharma to Present Results of Phase 2 Trial of ZS-9 at 2014 American College of Cardiology's Annual Scientific Session03-27-14
Corgenix and Research Partners to Expand Ebola Virus Testing Capabilities in Sierra Leone03-27-14
Guided Therapeutics Submits Request for Face to Face Meeting with FDA; Receives Notification on PMA Extension for LuViva® Advanced Cervical Scan03-27-14
ArtVentive Medical Group, Inc. Announces New Catheter-Assisted Endovascular Tumor Treatment System03-27-14
Retrophin Completes Acquisition of Manchester Pharmaceuticals03-27-14
pSivida Announces Resubmission of New Drug Application for ILUVIEN®03-27-14
Exact Sciences? Stock Trading Halted Today; FDA Advisory Committee Meeting to Review Premarket Approval Application03-27-14
Clovis Oncology's CO-1686 Demonstrates Compelling Clinical Activity and Progression-free Survival (PFS) in Updated Phase 1 Study Results in Patients with Non-small Cell Lung Cancer (NSCLC)03-27-14
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Guided Therapeutics Reports Fourth Quarter and 2013 Results03-26-14
Fitch Affirms AmeriCredit Automobile Receivables Trust 2013-203-26-14
U.S. Prescribing Information for Thyrogen Revised to Include Use of Wider Range of Radioiodine in Patients03-26-14
NuvoLase Inc. Receives TGA Clearance to Market the PinPointe? FootLaser? in Australia03-26-14
Navidea Announces Presentations Highlighting NAV4694 Beta-Amyloid, PET Imaging Agent at the German Society of Nuclear Medicine Congress03-26-14
CHPA Statement on Part 15 Public Hearing on OTC Monograph System03-25-14
TransEnterix, Inc. Provides Update on Investor & Analyst Event03-25-14
Actinium to Commence Trading on NYSE MKT on March 26, 201403-25-14
PHT Corporation Launches New App of FDA Roadmap to Patient-Focused Outcome Measurement in Clinical Trials for Android Phones and Tablets03-25-14
Voyager Therapeutics Expands and Strengthens Scientific and Clinical Leadership to Advance Life-Changing Gene Therapies for CNS Disorders03-25-14
DexCom Receives FDA Warning Letter for Administrative Deficiencies in its MDR Reporting03-25-14
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Actinium to Present at BioCentury 21st Annual Future Leaders in the Biotech Industry Conference on March 2803-25-14
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Adding Multi-Media Materials: OTEZLA® (apremilast) ? First Oral Therapy Approved by the U.S. Food and Drug Administration for the Treatment of Adults with Active Psoriatic Arthritis03-24-14
Genocea's Therapeutic Vaccine for Herpes Simplex-2 Infection Shows Highly Significant Reductions in Clinical Symptoms at 6 Months03-24-14
King Faisal Specialist Hospital & Research Centre Selects RIVA as IV Compounding Solution03-24-14
New Data Regarding Transfusion-Related Reactions for Fenwal InterSol? Solution03-24-14
BEAT BioTherapeutics Appoints Dr. Sam L. Teichman as Chief Medical Officer03-24-14
Agios Enrolls First Patient in Phase 1 Study of AG-120 in Advanced Solid Tumors with an IDH1 Mutation03-24-14
Merck to Present New Data for Investigational Hepatitis C Treatments MK-5172 and MK-8742 at EASL Annual Meeting/The International Liver Congress? 201403-24-14
St. Jude Medical Announces Global Launch of Optisure Defibrillation Lead03-24-14
St. Jude Medical annuncia il lancio su scala mondiale dell'elettrodo per defibrillazione Optisure03-24-14
St. Jude Medical meldet weltweite Produkteinführung der Optisure Defibrillationselektrode03-24-14
St. Jude Medical Announces FDA Approvals of New Pacemakers03-24-14
Kamada Announces Initiation of a Phase 2 U.S. Clinical Trial of Inhaled AAT to Treat Alpha-1 Antitrypsin Deficiency03-24-14
Samenvatting: OTEZLA eerste goedgekeurde orale therapie voor de behandeling van volwassenen met arthritis psioratica03-24-14
Otsuka Pharmaceutical's Samsca® Approved in Japan as the World's First Drug Therapy for ADPKD, a Rare Kidney Disease03-24-14
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OTEZLA® (Apremilast) ? erstes von der US-Gesundheitsbehörde FDA für die orale Therapie erwachsener Patienten mit aktiver Psoriasis-Arthritis zugelassenes Medikament03-23-14
L'OTEZLAMD (apremilast) est le premier médicament administré par voie orale approuvé par l'U.S. Food and Drug Administration pour le traitement des adultes atteints de polyarthrite psoriasique évolutive03-22-14
OTEZLA® (apremilast): Primer fármaco de administración oral aprobado por la Administración de Medicamentos y Alimentos de los Estados Unidos para el tratamiento de adultos con artritis psoriásica activa03-22-14
OTEZLA® (apremilast) ? Primeiro Medicamento Via Oral Aprovado pela FDA (Food & Drug Administration) dos EUA para Tratamento de Adultos com Artrite Psoriásica Ativa03-22-14
Riassunto: OTEZLA® (apremilast) ? Prima terapia orale approvata dalla FDA (l'agenzia federale per il controllo dei mercati farmaceutici e alimentari degli USA) per il trattamento dell'artrite psoriatica attiva negli adulti03-21-14
OTEZLA® (apremilast) ? First Oral Therapy Approved by the U.S. Food and Drug Administration for the Treatment of Adults with Active Psoriatic Arthritis03-21-14
PDS Set to Launch New Products and Branding at Society of Toxicology Annual Meeting03-21-14
FDA Approves Xolair® (omalizumab) for People with Chronic Idiopathic Urticaria (CIU), a Form of Chronic Hives03-21-14
St. Jude Medical maakt de Europese introductie bekend van de Prodigy neurostimulator voor ruggenmergstimulatie met burst technologie03-21-14
St. Jude Medical annuncia il lancio in Europa di Prodigy, il sistema per la stimolazione del midollo spinale con tecnologia a raffiche (BURST)03-21-14
Suit Charges St. Jude Riata Heart Lead is a Defective Device, Lieff Cabraser Announces03-21-14
Genzyme's Lemtrada? Approved in Brazil for Treatment of Multiple Sclerosis03-21-14
Health Canada Approves Biogen Idec's Long-Acting ALPROLIX? Therapy for Hemophilia B03-21-14
Kamada to Report Top-Line Data from Phase 2/3 Clinical Trial of Inhaled AAT to Treat Alpha-1 Antitrypsin Deficiency by Late April or Early May03-21-14
Harvard Apparatus Regenerative Technology Spotlighted by Fast Company Co.Exist03-21-14
TapImmune Inc. is Pleased to Announce the Filing of New Intellectual Property Surrounding its Novel and Proprietary Platform Expression System PolyStart?03-20-14
Pfizer's Investigational Vaccine Candidate Bivalent rLP2086 Receives U.S. Food and Drug Administration Breakthrough Therapy Designation for Potential Prevention of Meningococcal B Disease03-20-14
NDA for Eagle Pharmaceuticals? Orphan Drug Ryanodex® for the Treatment of Malignant Hyperthermia Accepted by FDA, Priority Review Granted03-20-14