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About 800 results for "pdufa"

PDUFA date approaches for Fibrocaps BLA

The PDUFA date for the FDA's review of The Medicines Company's (MDCO +0.3%) Biologics License Application (BLA) for its hemostatic agent, Fibrocaps, is January 31. Since this is Saturday, the agency may announce its decision on Friday, January 30. ... Seeking Alpha, 16 hours ago
PDUFA date approaches for Zohydro sNDA Seeking Alpha, 16 hours ago
PDUFA approaches for NPS Pharma's Natpara Seeking Alpha, 6 days ago

1 images for "pdufa"

GlobeNewswire, 3 weeks ago

What Investors Are Looking For In NPS Pharmaceuticals Ahead Of A Potential Sale

NPS Pharmaceuticals, Inc. (NASDAQ: NPSP ) is gaining interest ahead of the company's Prescription Drug User Fee Act (PDUFA) decision on January 24, 2014. On Monday, the Wall Street Journal reported that Goldman Sachs Group Inc (NYSE: GS ) began ...
 Yahoo! Finance3 weeks ago Shire (SHP LN): Pipeline to deliver 2015 catalysts; PT +17% to 5500p  European Pharmaceutical Review1 week ago Shire's Takeover of NPS Pharmaceuticals: What Wall Street's Saying  TheStreet.com2 weeks ago UPDATE: Jefferies Raises Price Target On NPS Pharmaceuticals Ahead Of Acquisition By Shire  Benzinga.com2 weeks ago

Actavis and Gedeon discloses USFDA receipt of Cariprazine NDA resubmission for schizophrenia and manic or mixed episodes in bipolar I disorder

Pharmaceutical company Actavis The companies expect cariprazine's Prescription Drug User Fee Act (PDUFA) date to be in the second quarter of 2015. Cariprazine, which is an investigational drug, is an atypical antipsychotic for the treatment of ...
 BusinessWeek3 weeks ago Hungary Richter and Actavis announce FDA receipt of NDA resubmission for Cariprazine  TeleTrader.com3 weeks ago Actavis and Gedeon Richter Announce FDA Receipt of NDA Resubmission for Cariprazine  4 Traders2 weeks ago Actavis Announces FDA Receipt Of NDA Resubmission For Cariprazine  Pharmacy Choice3 weeks ago

FDA sets PDUFA date for Patiromer FOS

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 Seeking Alpha3 weeks ago

Relypsa Announces October 21, 2015 as PDUFA Date for NDA for Patiromer for Oral Suspension

REDWOOD CITY, Calif., Jan. 5, 2015 (GLOBE NEWSWIRE) -- Relypsa, Inc. (Nasdaq:RLYP), today announced that the U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) action date of October 21, 2015
 Drugs.com2 days ago Relypsa Announces Assignment of October 21, 2015 PDUFA Date for New Drug Application for Patiromer for Oral Suspension  Benzinga.com3 weeks ago Relypsa, Inc. Announces Assignment Of October 21, 2015 PDUFA Date For New Drug Application For Patiromer For Oral Suspension  BioSpace3 weeks ago

Rockwell Medical volatility elevated into PDUFA

Stock Market XML and JSON Data API provided by FinancialContent Services, Inc. Nasdaq quotes delayed at least 15 minutes, all others at least 20 minutes. Markets are closed on certain holidays. Stock Market Holiday List By accessing this page, ...
 BioSpace5 days ago
Pharmaceutical Business Review

Sanofi's BLA for hypercholesterolemia drug receives FDA acceptance for review

Regeneron Pharmaceuticals, Inc. and Sanofi have received the FDA acceptance for priority review of the biologics license application, or BLA, for Praluent, or alirocumab, which is intended for the treatment of patients with hypercholesterolemia.
 Individual.com3 hours ago Sanofi and Regeneron's Praluent BLA gains priority review from US FDA26-01-2015  Pharma Letter1 day ago FDA accepts for priority review Sanofi and Regeneron's BLA for hypercholesterolemia drug Praluent  Pharmaceutical Business Review2 days ago Amgen Leapfrogged In Race For New Cholesterol Drug  Forbes.com2 days ago

Vertex Pharmaceuticals' (VRTX) CEO Jeffrey Leiden on Q4 2014 Results - Earnings Call Transcript

Operator Good evening, ladies and gentlemen, and thank you for joining the Vertex Pharmaceuticals Incorporated Fourth Quarter 2014 Financial Results Conference Call. [Operator Instructions] As a reminder, this call is being recorded. I would now ...
 Seeking Alpha6 hours ago Vertex Pharma Expects 2015 Kalydeco Revenues Of $560 Mln To $580 Mln In 2015  RTTNews.com2 weeks ago Vertex Outlines 2015 Business Priorities to Support the Development, Approval and Launch of New Medicines for the Treatment of People with Cystic Fibrosis  BusinessWeek2 weeks ago VERTEX PHARMACEUTICALS : Pharma Expects 2015 Kalydeco Revenues Of $560 Mln To $580 Mln In 2015  4 Traders2 weeks ago

INC Research: A Biopharma Derivative With A Bright Future

Summary INCR offers a profitable service in a really hard to execute space. INCR has a growing-more-solid balance sheet, now profitable operations and free cash flow generation. Buy INCR immediately, as the shares are poised to move higher over ...
 Seeking Alpha11 hours ago

Roche Holding's (RHHBY) CEO Severin Schwan on Q4 2014 Results - Earnings Call Transcript

Roche Holding Ltd. ( OTCQX:RHHBY ) Q4 2014 Earnings Conference Call January 28, 2015 10:00 AM ET Severin Schwan Good afternoon ladies and gentlemen, and welcome to our Year End briefing. 2014 was a good year for Roche, we achieved our financial ...
 Seeking Alpha11 hours ago
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