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About 800 results for "pdufa"

PDUFA date tomorrow for Xifaxan expanded use

The FDA's decision date, or PDUFA date, is tomorrow regarding Salix Pharmaceuticals' (VRX -0.8%) supplemental Biologics License Application (sBLA) for the use of Xifaxan (rifaximin) for the treatment of irritable bowel syndrome with diarrhea. Seeking Alpha, 23 hours ago

4 images for pdufa

GlobeNewswire, 1 month ago
Canadian Business Journal, 1 month ago
I Stock Analyst, 1 month ago
Nasdaq, 1 month ago

Next Week In Biotech: Salix/Valeant PDUFA, ASCO, Brain Tumor Summit

 Seeking Alpha5 days ago Next Week In Biotech: ASCO Abstracts, Pernix PDUFA, Celladon Earnings  Seeking Alpha2 weeks ago Next Week In Biotech: Baxter-Baxalta, BioLine RX Earnings  Seeking Alpha1 week ago Seeking Alpha's Biotech Weekly: A Gilead Victory, Celladon Crumbles, And More  Seeking Alpha3 weeks ago

Food and Drug Administration Advisory Panel Voted 12 to 1 to Recommend Approval of ORKAMBI(TM) (lumacaftor/ivacaftor) to Treat People with Cystic Fibrosis Ages 12 and Older Who Have Two Copies of the F508del Mutation

-FDA decision expected by July 5, 2015 PDUFA date- -Approximately 8,500 people with cystic fibrosis in the U.S. have two copies of the F508del mutation and are ages 12 and older- BOSTON--(BUSINESS WIRE)-- Vertex Pharmaceuticals ...
 CNBC2 weeks ago VERTEX PHARMACEUTICALS : Food and Drug Administration Advisory Panel Voted 12 to 1 to Recommend Approval of ORKAMBI (lumacaftor/ivacaftor) to Treat People with Cystic Fibrosis Ages 12 and Older Who Have Two Copies of the F508del Mutation  4 Traders2 weeks ago Vertex Pharmaceuticals: FDA Advisory Panel Voted 12 to 1 to Recommend Approval of ORKAMBI (lumacaftor/ivacaftor) [Professional Services Close - Up]  Pharmacy Choice1 day ago VERTEX PHARMACEUTICALS : FDA Advisory Panel Voted 12 to 1 to Recommend Approval of ORKAMBI (lumacaftor/ivacaftor)  4 Traders1 day ago
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New Patent Issued for Eagle Pharmaceuticals Bendamustine Rapid Infusion Product

"We look forward to the PDUFA date for the rapid infusion bendamustine product in December, and if approved we believe the additional milestone and royalty payments will expedite our ability to deliver long term, sustainable growth." WOODCLIFF ...
 Noodls1 week ago Eagle Pharmaceuticals: The Eagle Has Soared Too High, Too Soon  Seeking Alpha4 days ago Eagle Pharmaceuticals Receives Patent for Rapid Infusion Product  PharmaceuticalProcessing1 week ago Eagle Pharma awarded patent covering rapid infusion bendamustine  Seeking Alpha1 week ago
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PDUFA Reauthorization Process Begins

Reauthorization of the Prescription Drug User Fee Act is officially underway with the FDA's announcement of a July 15 public meeting to assess the current PDUFA V. In particular, the FDA wants to know how PDUFA might be tweaked to improve the ...
 FDA News1 week ago FDA kicks off reauthorization process for PDUFA  Pharmacist.com1 week ago Public Meeting: Medical Device User Fee Reauthorization, July 13, 2015 (proposed)  U.S. Food and Drug Administration1 week ago

FDA Accepts BPL's Amended BLA Submission for Coagadex® (Coagulation Factor X, Human)

Bio Products Laboratory, Ltd. (BPL), a leading manufacturer of plasma-derived therapies, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's amended Biologics License ...
 Franklin Credit Management Corporation15 minutes ago
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Synageva BioPharma Submits Kanuma„¢ (Sebelipase Alfa) Application For LAL Deficiency In Japan

/PRNewswire/ -- Synageva BioPharma Corp. (NASDAQ: GEVA), a biopharmaceutical company developing therapeutic products for rare disorders, today announced the submission of a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare ...
 TickerTech.com17 hours ago Synageva BioPharma Submits Kanuma(TM) (Sebelipase Alfa) Application For LAL Deficiency In Japan  Red Orbit24 minutes ago Synageva BioPharma Submits Kanuma (Sebelipase Alfa) Application For LAL Deficiency In Japan  AndhraNews.net3 hours ago Synageva BioPharma Submits Kanuma??? (Sebelipase Alfa) Application For LAL Deficiency In Japan  Tutorial Finder17 hours ago
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Cerulean Pharma Inc. (CERU)'s CRLX101 Receives Orphan Drug Designation From The FDA For The Treatment Of Ovarian Cancer 5/26/2015

CAMBRIDGE, Mass.--( BUSINESS WIRE )-- Cerulean Pharma Inc. (Nasdaq:CERU) today announced that the U.S. Food and Drug Administration, or FDA, has granted orphan drug designation to CRLX101 for the treatment of ovarian cancer. ...
 ClinicSpace19 hours ago Cerulean Pharma Says FDA Grants Orphan Drug Status To CRLX101 In Ovarian Cancer  RTTNews.com1 day ago Cerulean's CRLX101 Receives Orphan Drug Designation from the FDA for the Treatment of Ovarian Cancer  Nasdaq1 day ago FDA Grants Orphan Drug Designation to Cerulean's CRLX101 Nanoparticle-Drug Conjugate  Azonano3 hours ago
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Regeneron Pharmaceuticals (REGN) Analysts Recent Ratings Updates

Several brokerages have updated their recommendations and price targets on shares of Regeneron Pharmaceuticals (NASDAQ: REGN) in the last few weeks: 5/21/2015 Regeneron Pharmaceuticals had its neutral rating reaffirmed by analysts at Piper ...
 Ticker Report7 hours ago
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Nutra Pharma Announces Orphan Drug Applications for RPI-78M

CORAL SPRINGS, FL -- (Marketwired) -- 05/26/15 -- Nutra Pharma Corporation ( OTC: NPHC ), a biotechnology company that is developing treatments for Multiple Sclerosis (MS), Human Immunodeficiency Virus (HIV), Adrenomyeloneuropathy (AMN) and Pain, ...
 Town Hall1 day ago Nutra Pharma Corp. Announces Orphan Drug Applications For RPI-78M  BioSpace18 hours ago
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