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About 800 results for "pdufa"

AcelRx Pharmaceuticals Confirms July 27, 2014 PDUFA Date for Zalviso

AcelRx volatility elevated into July 27 PDUFA date for Zalviso

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, ... Wall Street Business Network, 2 days ago

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ABC News 4 Charleston, 3 days 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 Alpha2 weeks 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 Network2 weeks ago GULFO: 'Right to try' not just another bandage on a chronic wound  Washington Times2 weeks ago GULFO: Right to try not just another bandage on a chronic wound  Washington Times2 weeks 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 ...
 BioMedReports2 weeks ago

Envarsus(R) Receives European Marketing Authorization for Treatment of Both Kidney and Liver Transplant Patients

/PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) and Chiesi Farmaceutici S.p.A. today announced that the European Commission (EC) has granted marketing authorization for Envarsus(R) for the prevention of organ rejection in adult kidney and ...
 Scottrade31 minutes ago Envarsus® Receives European Marketing Authorization for Treatment of Both Kidney and Liver Transplant Patients  TMC Net8 minutes ago

Gilead Sciences Posts 2Q 2014 Financial Results

Gilead Sciences has reported its results of operations for the quarter ended June 30. In its release on July 23, the company noted that total revenues for the second quarter of 2014 increased to $6.53 billion compared to $2.77 billion for the second ...
 Individual.com1 hour ago Gilead Sciences maakt financiële resultaten tweede kwartaal 2014 bekend  Business Wire20 hours ago Gilead Sciences gibt Finanzergebnisse für zweites Quartal 2014 bekannt  Business Wire1 day ago Gilead Sciences annonce ses résultats financiers pour le deuxième trimestre2014  Business Wire2 days ago

Baggy Eyes Serum Review Posted for Men and Women at Cherry News Website

(Date:7/27/2014)... a powerful drug given at the time of a ... of rejection, but that it also allows a less ... the operation. , The key results are reported in ... Transplant Congress in San Francisco today. They will help ... combinations of ...
 Bio-Medicine5 hours ago
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