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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, 5 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 ...
 CNBC2 weeks ago Navidea Biopharmaceuticals Receives $1.1Million PDUFA Filing Fee Refund For Award Of Orphan Drug Status; Platinum Partners Reaffirms Commitment To Line Of Credit  BioSpace2 weeks 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 Financials2 weeks 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 Traders2 weeks 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 Hall2 weeks 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 Closes $58.5 Million Public Offering of Common Stock

WIXOM, Mich., Nov. 25, 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 ...
 Scottrade1 day ago Rockwell Medical : Closes $58.5 Million Public Offering of Common Stock  4 Traders1 day ago Rockwell Medical Prices $58.5 Million Public Offering of Common Stock  4 Traders1 week ago ROCKWELL MEDICAL : Announces $55 Million Proposed Public Offering of Common Stock  4 Traders1 week ago
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InterMune(R) Supports Launch of First Ever European Patient Charter on Idiopathic Pulmonary Fibrosis (IPF) in European Parliament

/PRNewswire/ -- InterMune(R) is pleased to support the launch of a new European Patient Charter for people with idiopathic pulmonary fibrosis which is being presented in the European Parliament on 30th September, during IPF World Week 2014. The ...
 Individual.com15 hours ago

Immunomedics' Veltuzumab Receives Orphan Drug Status

Immunomedics Inc. ( IMMU ) announced that the FDA has granted orphan drug status to its anti-CD20 antibody, veltuzumab, for the treatment of pemphigus. We note that orphan drug designation is usually granted to novel drugs or biologics targeting ...
 Yahoo! Finance2 days ago

Amgen Halts Rilotumumab Trials in Advanced Gastric Cancer

Amgen said today it halted all clinical studies of its compound rilotumumab (formerly AMG 102) in advanced gastric cancer —including two Phase III studies—after the data monitoring committee for one of the trials found more deaths in the ...
 Genetic Engineering News2 days ago

BMS, Five Prime Plan Cancer Combo Trial, in $30M+ Expansion of Alliance

Bristol-Myers Squibb (BMS) and Five Prime Therapeutics said today they will launch a Phase Ia/Ib study to assess the safety, tolerability, and preliminary efficacy of combining the pharma giant's Opdivo (nivolumab) with the biotech's monoclonal ...
 Genetic Engineering News2 days ago

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 ...
 Stockwatch1 week ago Vernalis PLC Change Of Year-End And Commercial Business Update  BioSpace6 days ago Vernalis : Change of Year End & Commercial Business Update  4 Traders1 week ago Change of Year End & Commercial Business Update  Noodls1 week ago
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