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About 799 results for "pdufa"

Impax Pharma: FDA Extends PDUFA Date For Review Of RYTARY NDA

Impax Pharmaceuticals, the branded products division of Impax Laboratories Inc. (IPXL: Quote), announced that the U.S. FDA has extended the PDUFA date for its review of the RYTARY (IPX066) New Drug Application from October 9, 2014, to January 9, ... RTTNews.com, 6 days ago
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6 images for pdufa

FDA News, 2 weeks ago
Regulatory Affairs Professionals Society, 1 month ago
MedPage Today, 1 month ago
ABC News 4 Charleston, 1 month ago
Scottrade, 1 month ago
Motley Fool, 2 months ago

PDUFA date approaches for Iluvien

The FDA PDUFA date for Alimera Sciences' ( ALIM -0.8% ) NDA for Iluvien (190 mcg fluocinolone acetonide intravitreal implant in applicator) is September 26, 2014. The company resubmitted its application in April after addressing the issues cited in ...
 Seeking Alpha5 days ago
Pharma Letter

FDA accepts Tuzistra XR (CCP-01) NDA for full review

The FDA has set a Prescription Drug User Fee Act (PDUFA) target date for conclusion of its review of 30 April 2015 . Under the exclusive licensing agreement announced in February 2012 , Tris is developing, on behalf of Vernalis, up to six unique ...
 Morningstar.com1 week ago Vernalis: Tris Pharma's Tuzistra XR NDA Accepted by FDA for Full Review  Individual.com5 days ago Vernalis and Tris Pharma confirm the US Food and Drug Administration has confirmed that the New Drug Application for Tuzistra XR (CCP-01) has been accepted for full review. This triggers a milestone payment from Vernalis to Tris. The FDA has set a Prescri  Money Week1 week ago VERNALIS : FDA accepts TuzistraTM XR NDA for full review  4 Traders1 week ago
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FDA Advisory Committee Recommends Approval of Natpara® for Long-Term Treatment of Hypoparathyroidism

NPS Pharma to host conference call today at 5:30 PM EDT PDUFA date for Natpara BLA is October 24, 2014 Company Website: http://www.npsp.com BEDMINSTER, N.J. -- (Business Wire) NPS Pharmaceuticals, Inc. (NASDAQ:NPSP), a global ...
 Stockwatch1 week ago CORRECTING AND REPLACING/ FDA Advisory Committee Recommends Approval of Natpara(R) for Long-Term Treatment of Hypoparathyroidism  Scottrade1 week ago NPS PHARMACEUTICALS : FDA Advisory Committee Recommends Approval of Natpara® for Long-Term Treatment of Hypoparathyroidism  4 Traders1 week ago FDA Posts Briefing Materials for Advisory Committee Meeting Reviewing Natpara® for Hypoparathyroidism  BusinessWeek1 week ago
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Results of Clinical Trials, New Drug Applications, Leadership Appointments, and Scheduled Earnings - Research Reports on Biogen, Salix, Express Scripts, Stryker and Shire

/PRNewswire/ -- Today, Analysts Review released its research reports regarding Biogen Idec Inc. ( NASDAQ: BIIB ), Salix Pharmaceuticals Ltd. ( NASDAQ: SLXP ), Express Scripts Holding Company ( NASDAQ: ESRX ), Stryker Corporation ( NYSE: SYK ) and ...
 RCL Advisors3 hours ago New Product Launch, Accelerated Drug Approvals, Study Initiation, and Market Activity - Research Reports on Johnson & Johnson, Merck, Medtronic, Pharmacyclics and NPS Pharma  A.M. Best1 week ago NPS PHARMACEUTICALS : New Product Launch, Accelerated Drug Approvals, Study Initiation, and Market Activity - Research Reports on Johnson & Johnson, Merck, Medtronic, Pharmacyclics and NPS Pharma  4 Traders1 week ago
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Key Pharma Events For the Week Ahead

BidnessEtc highlights major events for pharmaceutical and biotech companies scheduled this week Page 1 of 2 Click Ticker to See live coverage This week's highlights include the European Society for Medical Oncology (ESMO) Congress ...
 Bidness Etc21 hours ago New Haven Pharmaceuticals Files DURLAZA New Drug Application  BioSpace1 week ago
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Sovaldi sales suggest payer tolerance for drug [Medical Marketing and Media]

[September 22, 2014] (Medical Marketing and Media Via Acquire Media NewsEdge) THE BIG STORY of Gilead's second quarter was supposed to be Sovaldi's astronomical sales figures. But its progress on pro- tease inhibitor GS-9857-which ...
 TMC Net1 day ago Sovaldi sales suggest payer "tolerance" for drug  Insurance News Net1 day ago Buy The Dip In Gilead: Why A Decrease In Quarterly Sovaldi Revenue Is Expected  Seeking Alpha6 days ago Gilead's New Sovaldi To Be Even More Expensive For US Patients  Bidness Etc1 week ago

9/22/14 - Saxenda® for the treatment of obesity receives positive 14-1 vote in favor of approval from FDA Advisory Committee

9/22/14 - Saxenda for the treatment of obesity receives positive 14-1 vote in favor of approval from FDA Advisory Committee By a News Reporter-Staff News Editor at Clinical Trials Week Novo Nordisk announced that the Endocrinologic and Metabolic ...
 Pharmacy Choice1 day ago Novo Nordisk receives positive vote from FDA Advisory Committee for approval of Saxenda  Pharmaceutical Business Review5 days ago NOVO NORDISK A/S : Saxenda® for the treatment of obesity receives positive 14-1 vote in favor of approval from FDA Advisory Committee  4 Traders5 days ago FDA Advisory Committee Votes 14-1 in Favor of Saxenda (liraglutide) for Obesity  Drugs.com1 week ago
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InterMune Reports Memorandum of Understanding in Connection with Consolidated Delaware Action

BRISBANE, Calif. , Sept. 19, 2014 /PRNewswire/ --InterMune, Inc. ( Nasdaq: ITMN ) today announced that it entered into a Memorandum of Understanding to settle the litigation in the Delaware Court of Chancery relating to the Agreement and Plan of ...
 Crawford Financial Planning3 days ago
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Orphan status for Navidea's Lymphoseek in head and neck cancers19-09-2014

US biotech company Navidea Biopharmaceuticals (NYSE MKT: NAVB) that its Lymphoseek (technetium Tc 99m tilmanocept) Injection has been granted Orphan Drug Designation by the US Food and Drug Administration for use in sentinel lymph node detection in ...
 Pharma Letter3 days ago Navidea Receives Orphan Drug Designation from FDA for Use of Lymphoseek® in Head and Neck Cancers  CNBC4 days ago Synthetic Biologics Secures Orphan Drug Designation for SYN-005 Treatment for Whooping Cough (Pertussis)  Individual.com6 days ago US FDA grants orphan drug status to Synthetic Biologics' SYN-005 to treat whooping cough  PharmaBiz1 week ago
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