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About 800 results for "pdufa"

FDA approval unlikely as PDUFA date approaches for Avanir

News Editor November 26 is the PDUFA date for the FDA's decision on Avanir Pharmaceuticals' (AVNR +0.9%) NDA for AVP-825, its investigational drug-device combination for the acute treatment of migraines. Approval is unlikely, though. Earlier this ... Seeking Alpha, 3 days ago
PDUFA Date Approaching BioMedReports, 1 week ago
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1 images for "pdufa"

Seeking Alpha, 3 weeks ago

Navidea Receives $1.1Million PDUFA Filing Fee Refund for Award of Orphan Drug Status; Platinum Partners Reaffirms Commitment to Line of Credit

DUBLIN, Ohio--(BUSINESS WIRE)-- Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB) today announced it has received a $1.1 million refund of the previously paid Prescription Drug User Fee Act (PDUFA) filing fee related to the granting of orphan drug ...
 CNBC1 week ago Navidea Biopharmaceuticals Receives $1.1Million PDUFA Filing Fee Refund For Award Of Orphan Drug Status; Platinum Partners Reaffirms Commitment To Line Of Credit  BioSpace1 week ago Navidea Receives $1.1M PDUFA Filing Fee Refund For Award Of Orphan Drug Status; Platinum Partners Reaffirms Commitment To Line Of Credit  Fat Pitch Financials1 week ago NAVIDEA BIOPHARMACEUTICALS : Receives $1.1Million PDUFA Filing Fee Refund for Award of Orphan Drug Status; Platinum Partners Reaffirms Commitment to Line of Credit  4 Traders1 week ago
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BiorCryst's Peramivir PDUFA Date Approaching

As you may know, BioCryst Pharmaceuticals, Inc (NASDAQ:BCRX) submitted New Drug Application with U.S Food and Drug Administration (FDA) for approval of Peramivir in U.S. The same drug has already been approved in Korea and Japan for treatment of ...
 BioMedReports1 week ago

Navidea Biopharma (NAVB) Receives $1.1M Refund from Lymphoseek PDUFA Filing

Visit StreetInsider.com at http://www.streetinsider.com/news.php-st=p&id=9998333 for the
 Town Hall1 week ago Chardan Capital Boosts Price Target on Rockwell Medical (RMTI) to $27; Sees Triferic Approval by PDUFA Date  Financial Content2 weeks ago
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Securities Technology Monitor

Rockwell Medical Prices $58.5 Million Public Offering of Common Stock

WIXOM, Mich., Nov. 19, 2014 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (Nasdaq:RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for ...
 4 Traders4 days ago ROCKWELL MEDICAL : Announces $55 Million Proposed Public Offering of Common Stock  4 Traders6 days ago Rockwell Medical Announces $55 Million Proposed Public Offering of Common Stock  FirstWord Pharma6 days ago Rockwell Medical Announces Presentation Schedule for Triferic Clinical Posters at the American Society of Nephrology (ASN) Meeting November 2014  Vision Monday1 week ago
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Vernalis Change of Year-End and Commercial Business Update

Vernalis PLC (LSE: VER); (PINKSHEETS: VNLPY) LSE: VER LSE: VER Vernalis plc today announces a change to its accounting reference date and financial year end from 31 December to 30 June and provides an update on its cough cold pipeline since it ...
 Stockwatch6 days ago Vernalis PLC Change Of Year-End And Commercial Business Update  BioSpace3 days ago Vernalis : Change of Year End & Commercial Business Update  4 Traders6 days ago Change of Year End & Commercial Business Update  Noodls6 days ago
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Pharmaceutical Business Review

FDA Accepts Amgen's Biologics License Application For LDL Cholesterol-Lowering Medication Evolocumab

By a News Reporter-Staff News Editor at Pharma Business Week -- Amgen (NASDAQ: AMGN) announced that the U.S. Food and Drug Administration (FDA) has accepted for review Amgen's Biologics License Application (BLA) for evolocumab for the treatment of ...
 4 Traders4 days ago FDA accepts Amgen's evolocumab BLA for review  News-Medical.Net1 week ago US FDA accepts Amgen's BLA for evolocumab for treatment of high cholesterol  PharmaBiz1 week ago FDA accepts to review Amgen's BLA for LDL cholesterol-lowering drug evolocumab  Pharmaceutical Business Review1 week ago
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Bio Blast Pharma Receives Orphan Drug Designation From U.S. FDA for Cabaletta for the Treatment of Spinocerebellar Ataxia Type 3

TEL AVIV, Nov. 19, 2014 (GLOBE NEWSWIRE) -- Bio Blast Pharma Ltd. (Nasdaq:ORPN), a clinical-stage biotechnology company committed to developing clinically meaningful therapies for patients with rare and ultra-rare genetic diseases, announced today ...
 Financial Content5 days ago Basilea reports granting of U.S. orphan drug de...  MoneyExtra2 weeks ago
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Knight Sells Priority Review Voucher to Gilead

- Knight Therapeutics Inc., (TSX:GUD) through one of its wholly owned subsidiaries ("Knight"), today announced the sale of its Neglected Tropical Disease Priority Review Voucher ("PRV"). The PRV was granted to Knight in March of this year with the ...
 4 Traders5 days ago
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BioMedReports

Biotech Watchlist Update: Small-Cap Biotechs Struggle to Rebound

When the biotechnology market hit a speed bump in early 2014, every stock in the sector was jolted. Large-cap biotech and big pharma have largely recovered, but small- and micro-cap companies haven't yet entirely recouped the losses. The ...
 BioMedReports5 days ago What's Done Better for Investors: Small Biotechs or Big Pharma?  Equities.com1 week ago
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