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About 800 results for "pdufa"

AcelRx Pharmaceuticals Confirms July 27, 2014 PDUFA Date for Zalviso

AcelRx Pharmaceuticals Confirms July 27, 2014 PDUFA Date for Z...

REDWOOD CITY, Calif. The company recently learned that a rumor circulated online stating the Food and Drug Administration (FDA) had approved Zalviso. As of July 24, 2014 About AcelRx Pharmaceuticals, Inc. AcelRx Pharmaceuticals, Inc. is a ... Pettinga Financial Advisors, 10 hours ago
AcelRx Pharma (ACRX) Active Ahead of PDUFA TVNewsCheck, 1 day ago

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PDUDA date set for PA8140/PA32540

The FDA accepts Pozen's (NASDAQ: POZN ) resubmission of its NDA for PA8140/PA32540 and sets a PDUFA date of December 20, 2014. The agency sent the company a CRL on April 25, 2014 citing deficiencies in the manufacturing facility of an ingredient ...
 Seeking Alpha1 week ago Pozen Resubmits PA NDA, PDUFA In Two Months?  Seeking Alpha3 weeks ago POZEN Resubmits PA8140/PA32540 NDA  CNBC3 weeks ago POZEN resubmits PA8140/PA32540 NDA to US FDA and expects PDUFA date by mid-July  Individual.com3 weeks ago
SPi World News

PDUFA date set for ATX-101

The FDA accepts Kythera Biopharmaceuticals' ( KYTH -3.7% ) NDA for ATX-101 (deoxycholic acid) and establishes a PDUFA date of May 13, 2015. It submitted its application on May 13 . If approved, it will be the first-in-class drug indicated for ...
 Seeking Alpha1 week ago CORRECTION: Kythera Reports FDA Acceptance of ATX-101 NDA, PDUFA Date Set at May 13, 2015  Pharmacy Choice2 weeks ago PDUFA date set for pirfenidone NDA  Seeking Alpha3 weeks ago The 4 Things You Need to Know About the FDA's New Drug Naming Guidance  Interbrand1 week ago

Rockwell gets small business waiver for its Triferic NDA

Jun 30 2014, 09:08 ET | About: Rockwell Medical, Inc. (RMTI) The FDA waives its PDUFA fee for Rockwell Medical's (RMTI) NDA for its iron replacement therapy Triferic. The Small Business Office of Government Contracting originally denied the ...
 Seeking Alpha3 weeks ago FDA Grants Rockwell's Request For $2.2 Mln PDUFA Fee Waiver - Quick Facts  RTTNews.com3 weeks ago

FDA Grants Spectrum Pharmaceuticals Accelerated Approval of Beleodaq (belinostat) for Injection

Early Action before PDUFA date of August 9, 2014 follows Priority Review Beleodaq to be launched through Spectrum's existing sales force Beleodaq is expected to be available to patients in less than 3 weeks Spectrum Pharmaceuticals (NasdaqGS: ...
 Reuters2 weeks ago BioAlliance Pharma: FDA approval of Beleodaq(TM) (belinostat)  Individual.com3 weeks ago Spectrum gets US FDA accelerated approval of Beleodaq to treat patients with relapsed/refractory PTCL  PharmaBiz2 weeks ago FDA Approves Beleodaq (belinostat)  Individual.com2 weeks ago

GULFO Another bandage on a chronic wound

FDA performance. Bandages before it that have failed include PDUFA, MDUFA, Breakthrough Therapy and the Transparency Initiative. The reason for failure is because none of them address the
 Big News Network1 week ago GULFO: 'Right to try' not just another bandage on a chronic wound  Washington Times1 week ago GULFO: Right to try not just another bandage on a chronic wound  Washington Times1 week ago

This PDUFA Play Looks Enticing

Informed Investors Make Money With Our Exclusive FDA Decisions Calendar and Subscriber Only Alerts! Why? Because They Know When Explosive Stock Moves Are Coming In Advance! Our Exclusive FDA Calendar includes a database with hundreds of ...
 BioMedReports1 week ago

Benzinga's Top #PreMarket Gainers

Qlik Technologies (NASDAQ: QLIK) shares surged 10.09% to $25.75 in pre-market trading after the company reported better-than-expected quarterly results. Baidu (NASDAQ: BIDU) shares jumped 7.36% to $219.31 in pre-market trading after the company ...
 Benzinga.com1 hour ago

Zerenex(TM) (Ferric Citrate) Long-Term Phase 3 Study Results Published in the Journal of the American Society of Nephrology

Data Demonstrate the Drug Candidate's Potential to Become the First Phosphate Binder to Increase Iron Stores While Reducing the Need for IV Iron and Erythropoiesis-Stimulating Agents in End-Stage Renal Disease Patients on Dialysis NEW YORK, ...
 EuroInvestor16 hours ago DGAP-News: Zerenex(TM) (Ferric Citrate) Long-Term Phase 3 Study Results Published in the Journal of the American Society of Nephrology (english)  Pharmacy Choice8 hours ago Zerenex (ferric citrate) long-term Phase 3 study results published in JASN  EurekAlert!16 hours ago Keryx Biopharmaceuticals Announces Issuance of Two U.S. Patents for Zerenex(TM) Covering Orally Administrable Forms of Ferric Citrate  Noodls1 week ago

Cubist Posts 2Q 2014 Financial Results

(Close-Up Media via COMTEX News Network) -- Cubist Pharmaceuticals, Inc. reported results for the second quarter ended June 30. In its release on July 22, the Company noted that financial highlights for the second quarter of 2014 (unaudited) ...
 PredictWallStreet9 hours ago CUBIST PHARMACEUTICALS : Posts 2Q 2014 Financial Results  4 Traders8 hours ago
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