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FDA Approves Pfizers Xeljanz for Rheumatoid Arthritis

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FDA approves a Pfizer NDA for Xeljanz (tofacitinib) to treat adults with moderately to severely active rheumatoid arthritis.

Latest FDA Warning Letters

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In todays batch of Warning Letters, FDA cites International Laboratories (Canada), NeuroMed Devices, and Sugih Instrumendo Abadi.

FDA Asks Advisors View on Diabetes Drug Heart Risk

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FDA medical reviewers raise a concern about cardiovascular safety for Novo Nordisks insulin degludec products.

Ireland Moves from Legislation Office to Advise Hamburg

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FDA commissioner Margaret Hamburg moves assistant commissioner for legislation Jeanne Ireland from the legislative shop to assume ...

Medivation Gets 5-page FDA-483 on Sponsor Monitoring

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FDA cites Medivation for sponsor monitor deficiencies in a just-released five-page FDA-483.

Roxane Labs Urges FDA to Reject Xyrem Petition

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Roxane Laboratories urges FDA to deny a Jazz Pharmaceuticals citizen petition seeking to block generic copies of Xyrem (sodium oxy...

Ventrus Plans NDA for Anal Fissure Cream

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Ventrus Biosciences says it will file an NDA for diltiazem hydrochloride cream for treating anal fissures in the fourth quarter ne...

FDA Panel Backs Raxibacumab for Anthrax

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FDAs Anti-Infective Drugs Advisory Committee votes in favor of GlaxoSmithKlines raxibacumab for treating inhalational anthrax.

FDA Warns Device Marketer for Unapproved Claims

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FDA warns a Tennessee Internet marketer that claims on its site and links to others make a light therapy product an unapproved and...

FDA-483 Cites Lab Vision Complaint Procedures

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An FDA inspection earlier this year of Lab Vision Corp. cites the firm over its complaint handling procedures.