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About 799 results for "pdufa"

Next Week In Biotech: Pacira PDUFA, Geron And Dendreon Report

Every week, Seeking Alpha aggregates expected biotech events in an effort to alert readers and contributors to upcoming catalysts. Crowdsourcing is key, so please let us know about any events we may have missed. Have a view on something that's ... Seeking Alpha, 1 day ago

3 images for "pdufa"

ClinicSpace, 5 days ago
Pharmaceutical Business Review, 3 weeks ago
GlobeNewswire, 1 month ago

Amgen's PDUFA date for melanoma drug BLA pushed out three months

Are you Bullish or Bearish on ? Bullish Bearish Neutral Results for ( ) Bullish Bearish Neutral Thanks for sharing your thoughts. Submit & View Results Skip to
 Seeking Alpha2 weeks ago
Franklin Credit Management Corporation

FDA Accepts BLA Filing For Synageva's Kanuma (Sebelipase Alfa); Grants Priority Review And Assigns PDUFA Date

LEXINGTON, Mass. , Feb. 23, 2015 /PRNewswire/ -- Synageva BioPharma Corp. ( NASDAQ: GEVA ), a biopharmaceutical company developing therapeutic products for rare disorders, announced today that the U.S. Food and Drug Administration (FDA) has accepted ...
 Franklin Credit Management Corporation5 days ago Press Release: FDA Accepts BLA Filing For Synageva's Kanuma(TM) (Sebelipase Alfa); Grants Priority Review And Assigns PDUFA Date  iMarketReports5 days ago Exelixis Announces Acceptance of New Drug Application for Cobimetinib in Combination with Vemurafenib for Treatment of Patients with BRAF V600 Mutation-Positive Advanced Melanoma  Morningstar.com1 week ago Synageva BioPharma Reports 2014 Full Year Financial Results  TickerTech.com1 day ago
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Immune Response BioPharma, Inc. Announces Remune FDA BLA Assignment PDUFA Goal December 22nd 2015

--(PR.com)-- Immune Response BioPharma, Inc., today announces receipt of Remune FDA BLA Assignment PDUFA goal date of December 22nd 2015 for Therapeutic HIV/AIDS Vaccine. The FDA previously granted Remune FDA Pediatric Orphan Designation in ...
 BioSpace1 week ago
MedPage Today

Multimedia Assets Now Available: FDA Approves Eisai's LENVIMA (lenvatinib) for the Treatment of Patients with Locally Recurrent or Metastatic, Progressive, Radioactive Iodine-Refractory Differentiated Thyroid Cancer

• Approval Granted Two Months Ahead of FDA Priority Review PDUFA Date Woodcliff Lake, NJ February 13, 2015 /PRNewswire/ — Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) approved the company's receptor tyrosine ...
 BioMedReports2 weeks ago D.C. Week: Harmony at Vaccine Hearing, Thyroid Ca Drug OK'd  MedPage Today2 weeks ago FDA Approves Eisai's LENVIMA (lenvatinib) for the Treatment of Patients with Locally Recurrent or Metastatic, Progressive, Radioactive Iodine-Refractory Differentiated Thyroid Cancer  Reuters2 weeks ago FDA Approves Thyroid Cancer Drug Early  MedPage Today2 weeks ago
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OPKO Announces Fourth Quarter Operating and Financial Results

OPKO Health, Inc. ( NYSE:OPK ) , a multi-national biopharmaceutical and diagnostics company, today reported operating and financial results for its fourth quarter ended December 31, 2014. Business Highlights Pfizer Collaboration ...
 Minyanville21 hours ago OPKO HEALTH : Announces Fourth Quarter Operating and Financial Results  4 Traders21 hours ago TESARO Announces Fourth-Quarter 2014 Operating Results  BioSpace1 week ago TESARO : Announces Fourth-Quarter 2014 Operating Results  4 Traders1 week ago
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Opdivo Gets Priority Review for NSCLC

Bristol-Myers Squibb Company BMY, -0.50% today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the Biologics Licensing Application (BLA) for Opdivo(nivolumab)for the treatment of patients with advanced ...
 American Journal of Managed Care23 hours ago U.S. Food and Drug Administration Accepts Biologics Licensing Application for Opdivo (nivolumab) for the Treatment of Advanced Squamous Non-Small Cell Lung Cancer  SearchBug1 day ago U.S. Food & Drug Administration Accepts Biologics Licensing..  ADVFN Australia1 day ago BRISTOL MYERS SQUIBB : U.S. Food and Drug Administration Accepts Biologics Licensing Application for Opdivo (nivolumab) for the Treatment of Advanced Squamous Non-Small Cell Lung Cancer  4 Traders1 day ago
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PACIRA PHARMACEUTICALS : Recaps 2014 Financial Results

Pacira Pharmaceuticals provided updates on the success of EXPAREL (bupivacaine liposome injectable suspension) for postsurgical pain in the United States and announced consolidated financial results for the fourth quarter and full year ended ...
 4 Traders14 hours ago Pacira Pharmaceuticals Posts 2014 Financial Results  Individual.com1 day ago Pacira Pharmaceuticals' (PCRX) CEO Dave Stack on Q4 2014 Results - Earnings Call Transcript  Seeking Alpha3 days ago Pacira Pharma Swings To Profit In Q4 - Quick Facts  RTTNews.com4 days ago
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Gilead Sciences (GILD) Presents at RBC Healthcare Conference (Transcript)

Feb. 27, 2015 9:35 PM ET | About: Gilead Sciences, Inc. (GILD) by: Gilead Sciences, Inc. (NASDAQ:GILD) RBC Healthcare Conference Call Executives Sung Lee - IR Robin Washington - EVP and CFO Analysts Michael Yee - RBC Capital Markets ...
 Seeking Alpha17 hours ago

FDA Advisory Committee Recommends Approval for Avedro's Riboflavin Ophthalmic Solutions with UVA Irradiation for Corneal Collagen Cross-Linking to Treat Progressive Keratoconus and Corneal Ectasia

Avedro, Inc., a Boston-based ophthalmic pharmaceutical and medical device company, announced today that on February 24, 2015 the U.S. Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee and ...
 RCL Advisors1 day ago Avedro Announces Date for FDA Advisory Committee Meeting  EON: Enhanced Online News1 week ago Avedro Sets Date for FDA Advisory Committee Meeting  Individual.com1 week ago Avedro, Inc. Announces Date For FDA Advisory Committee Meeting  BioSpace1 week ago
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