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About 800 results for "pdufa"

PHARMING : Reports On Financial Results First Half Year 2014
4 Traders

PDUFA date set for Relistor

for Salix Pharmaceuticals' (NASDAQ: SLXP ) sNDA for Relistor ( methylnaltrexone bromide) for treatment of opioid-induced constipation. Salix successfully appealed a CRL that the agency issued on July 27, 2012. Related tickers: (NASDAQ: PGNX ) ... Seeking Alpha, 2 weeks ago

5 images for pdufa

Regulatory Affairs Professionals Society, 1 week ago
MedPage Today, 3 weeks ago
ABC News 4 Charleston, 1 month ago
Scottrade, 1 month ago
Motley Fool, 1 month ago

Keryx Biopharma (KERX) Ramps on Positive Sentiment Ahead of Sept 7 PDUFA Date

Visit at for the
 Town Hall3 days ago Keryx Biopharmaceuticals (KERX) a Buy Ahead of PDUFA Date, Maxim Group Said  Town Hall3 days ago BofA/Merrill Lynch Remains Bullish on Orexigen (OREX) Ahead of Sept PDUFA Amid Update; PT Trimmed to $10  TVNewsCheck3 weeks ago
Regulatory Affairs Professionals Society

FDA, Industry Outline Impact of PDUFA V at 2012 RAPS

Posted 30 October 2012 By Alexander Gaffney, RF News Editor Renewed every five years, the Prescription Drug User Fee Act (PDUFA) is one of the single most important and successful pieces of ...
 Regulatory Affairs Professionals Society1 week ago
MedPage Today

HypeWatch: Did PDUFA Sacrifice Safety for Speed?

Public Health & Policy Published: Aug 5, 2014 It's true that 1992 was a watershed year for the FDA and pharmaceutical manufacturers. That was the year Congress passed the Prescription Drug User Fee Act, or PDUFA , under which the agency began ...
 MedPage Today3 weeks ago PDUFA and the Increase in Drug Withdrawals  Clinical Informatics News3 weeks ago HypeWatch: Another Look at Drug Safety Data  MedPage Today1 week ago
American Banking News

Biogen Idec Rating Reiterated by Morgan Stanley (BIIB)

The analysts wrote, Friday's approval was in-line with expectations following a 3 month PDUFA date extension. The label appears consistent with Avonex. Both drugs demonstrated similar annualized relapse rates (ARR) vs placebo, ~30-34% for Avonex and ...
 American Banking News1 week ago UPDATE: Morgan Stanley Reiterates On Biogen Idec Following Plegridy Approval  Benzinga.com1 week ago
Formulary Journal

Study Suggests that PDUFA's Expedited Process Encourages Approval of Dangerous Drugs

A recently published study compared warning and withdrawal rates for drugs released before and after the FDA began expediting drug approvals through PDUFA and found that drugs released after PDUFA passed were more likely to be withdrawn or have a ...
 Pharmaceutical Manufacturing Magazine3 weeks ago Safety of new drugs questioned by researchers  Formulary Journal2 weeks ago Researchers concerned about safety of new drugs  Medical News Today3 weeks ago


RNS Number : 3949Q Plethora Solutions Holdings PLC 29 August 2014  29 August 2014 PLETHORA SOLUTIONS HOLDINGS PLC ("Plethora" or the "Company") FOR THE SIX MONTHS ENDED 30 JUNE 2014 Plethora is pleased to ...
 TrustNet20 hours ago Plethora Solutions Holdings PLC Fundraising and Notice of General..  ADVFN UK20 hours ago Fundraising and Notice of General Meeting  TrustNet21 hours ago Plethora Solutions Holdings PLC INTERIM RESULTS  ADVFN UK20 hours ago

How to Pick Winning Biotechs Before the Herd

Liana Moussatos of Wedbush Securities doesn't wait for the catalyst to strike. She, like other successful investors, picks her targets and takes profits earlier, while less sophisticated investors wait for the press releases. In this interview with ...
 Equities.com1 day ago Wedbush Securities Liana Moussatos on the Art and Science of Picking Biotechs with Upside  Jutia Group1 week ago Wedbush Securities' Liana Moussatos On The Art And Science Of Picking Biotechs With Upside  Seeking Alpha1 week ago

FDA Approves ELELYSO(TM); Auxilium To Present CCH Data For AUX-CC-867 MULTICORD

Below is a look at some of the headlines for companies that made news in the healthcare sector on August 28, 2014 . {nfg} Pfizer Inc. (NYSE: PFE) and Protalix BioTherapeutics, Inc. (NYSE: PLX) announced the FDA approved ELELYSO (taliglucerase alfa) ...
 HispanicBusiness.com1 day ago

Auxilium Pharmaceuticals, Inc. To Present CCH Data For Concurrent Treatment Of Multiple Dupuytren's Cords At ASSH Annual Meeting

Related Stocks AUXL - Auxilium Pharmaceuticals Sym Last Chg Pct Volume AUXL18.59-0.04-0.21%521,400 CHESTERBROOK, Pa. , Aug. 28, 2014 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today ...
 Barchart2 days ago Auxilium Pharmaceuticals To Present CCH Data For Concurrent Treatment Of Multiple Dupuytren's Cords At Annual Meeting  BioSpace1 day ago
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