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FDA Rejects Pfizer sNDA for Xeljanz

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FDA issues Pfizer a complete response letter denying approval of a supplemental NDA for Xeljanz (tofacitinib citrate) for treating...

Medline Industries Recalls Mislabeled Acetaminophen

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FDA says Medline Industries is recalling one lot of acetaminophen tablets, 500mg, uncoated compressed tablets because they are mis...

BMS, Five Prime Partner on Immunology/Oncology Therapies

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Bristol-Myers Squibb and Five Prime Therapeutics enter into an agreement for developing Five Primes colony stimulating factor 1 re...

FDA OKs Edwards Sapien for Aortic Valve-in Valve Procedures

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FDA approves an Edwards Lifesciences PMA for its Sapien XT transcatheter heart valve for aortic valve-in-valve procedures.

Panel Meets on BioMarin NDA for Duchenne Muscular Dystrophy

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Federal Register Notice: FDAs Peripheral and Central Nervous System Drugs Advisory Committee will meet 11/24 to discuss BioMarins ...

FDA Helped BI More Than Pradaxa Patients: Report

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Slamming FDAs objectivity in approving Pradaxa, the Project on Government Oversight makes 11 recommendations to help the agency fo...

Workshop on Emerging Infectious Diseases Trial Designs

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FDA plans an 11/9-10 public workshop on Clinical Trial Designs for Emerging Infectious Diseases in Bethesda, MD.

More Concern About Califf Connections

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The Intercept says FDA commissioner-nominee Robert Califf has worked with many drug and other companies as a board member and cons...

Hospira Asks Court to Dismiss Part of Amgen Suit

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Hospira asks the Delaware federal court to dismiss some portions of an Amgen suit against it over Hospiras epoetin biosimilar prod...

Ways to Improve Combination Product Review

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An FDA Office of Planning study team recommends ways to improve efficiency and communication for intercenter combination product r...