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FDA related Press Releases

FDA Issues Safety Communication about an Ongoing Review of Stimulant Medications Used in Children with ADHD

Posted June 16, 2009

For Immediate Release: June 15, 2009 FDA Issues Safety Communication about an Ongoing Review of Stimulant Medications Used in Children with ADHD There may be an association between the use of

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FDA Provides PDUFA Target Agency Action Date For GTx's Toremifene 80 mg NDA

Posted March 5, 2009

FDA Provides PDUFA Target Agency Action Date For GTx's Toremifene 80 mg NDA MEMPHIS, Tenn.--(BUSINESS WIRE)--GTx, Inc. (Nasdaq: GTXI), today announced that the United States Food and Drug

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Former FDA Official Steven Niedelman Joins Crowell & Moring Health Care Group

Posted January 29, 2009

Former FDA Official Steven Niedelman Joins Crowell & Moring Health Care Group WASHINGTON, Jan. 28 /PRNewswire-USNewswire/ -- Steven M. Niedelman, former deputy associate commissioner for

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Merck Announces FDA Acceptance of Supplemental New Drug Application for ISENTRESS (raltegravir) in Adult Patients

Posted January 15, 2009

Merck Announces FDA Acceptance of Supplemental New Drug Application for ISENTRESS® (raltegravir) in Adult Patients Previously Untreated for HIV-1 WHITEHOUSE STATION, N.J., Dec. 12, 2008 - Merck

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ISTA Pharmaceuticals' New Drug Application for Bepreve(TM) Accepted for Review by U.S. Food and Drug Administration

Posted January 15, 2009

ISTA Pharmaceuticals' New Drug Application for Bepreve(TM) Accepted for Review by U.S. Food and Drug Administration IRVINE, Calif., Jan. 15 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc.... Read more...

Pharmasset and Roche Obtain FDA Consent to Start a Phase 2b Study With R7128 in Treatment Naive HCV Patients

Posted January 12, 2009

Pharmasset and Roche Obtain FDA Consent to Start a Phase 2b Study With R7128 in Treatment Naive HCV Patients PRINCETON, N.J., Jan. 12 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS)... Read more...

FDA Advisory Committee Recommends GTC Biotherapeutics' ATryn* (antithrombin [Recombinant])

Posted January 12, 2009

FDA Advisory Committee Recommends GTC Biotherapeutics' ATryn* (antithrombin [Recombinant]) If approved, ATryn will be first recombinant human antithrombin available in the U.S. ROCKVILLE,

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FDA Awaits Court's Entry of A Permanent Injunction Against Actavis Totowa, LLC

Posted January 12, 2009

FDA Awaits Court's Entry of A Permanent Injunction Against Actavis Totowa, LLC Company was making and marketing adulterated, misbranded and unapproved new drugs ROCKVILLE, Md., Jan. 9, 2009-Today,

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FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior for Antiepileptic Medications

Posted December 17, 2008

FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior for Antiepileptic Medications The U.S. Food and Drug Administration today announced it will require the manufacturers of

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Akorn, Inc. Responds to FDA Draft Guidance for Industry on Bioequivalence Recommendation for Vancomycin HCl

Posted December 16, 2008

Akorn, Inc. Responds to FDA Draft Guidance for Industry on Bioequivalence Recommendation for Vancomycin HCl LAKE FOREST, Ill.--(BUSINESS WIRE)--Akorn, Inc. (NASDAQ: AKRX) today provided the following

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