FDA related Press Releases
FDA Issues Safety Communication about an Ongoing Review of Stimulant Medications Used in Children with ADHD
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
... Read more...FDA Provides PDUFA Target Agency Action Date For GTx's Toremifene 80 mg NDA
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
... Read more...Former FDA Official Steven Niedelman Joins Crowell & Moring Health Care Group
Former FDA Official Steven Niedelman Joins Crowell & Moring Health Care Group WASHINGTON, Jan. 28 /PRNewswire-USNewswire/ -- Steven M. Niedelman, former deputy associate commissioner for
... Read more...Merck Announces FDA Acceptance of Supplemental New Drug Application for ISENTRESS (raltegravir) in Adult Patients
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
... Read more...ISTA Pharmaceuticals' New Drug Application for Bepreve(TM) Accepted for Review by U.S. Food and Drug Administration
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
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])
FDA Advisory Committee Recommends GTC Biotherapeutics' ATryn* (antithrombin [Recombinant]) If approved, ATryn will be first recombinant human antithrombin available in the U.S. ROCKVILLE,
... Read more...FDA Awaits Court's Entry of A Permanent Injunction Against Actavis Totowa, LLC
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,
... Read more...FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior for Antiepileptic Medications
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
... Read more...Akorn, Inc. Responds to FDA Draft Guidance for Industry on Bioequivalence Recommendation for Vancomycin HCl
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
... Read more...Paid Research Reports
- The Specialty Pharma Market Outlook: Key players, new company growth models and emerging opportunities
- Investigating Clinical Trial Costs: Comparative analysis of trial cost components in key geographies
- Clinical Trial Recruitment Strategies: Optimizing patient recruitment and retention in late stage clinical trials
- Pipeline Insight: Therapeutic Cancer Vaccines - Prospect of first approval set to reinvigorate interest from major companies
- Stakeholder Opinions: Vaccines in Emerging Markets (Asia) - Opportunities in China, India, South Korea and Taiwan
- Big Pharma Performance Before, During and Beyond the Global Recession
