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FDA approves a Pfizer NDA for Xeljanz (tofacitinib) to treat adults with moderately to severely active rheumatoid arthritis.[ Price : $8.95]
In todays batch of Warning Letters, FDA cites International Laboratories (Canada), NeuroMed Devices, and Sugih Instrumendo Abadi.[ Price : $8.95]
FDA medical reviewers raise a concern about cardiovascular safety for Novo Nordisks insulin degludec products.[ Price : $8.95]
FDA commissioner Margaret Hamburg moves assistant commissioner for legislation Jeanne Ireland from the legislative shop to assume ...[ Price : $8.95]
FDA cites Medivation for sponsor monitor deficiencies in a just-released five-page FDA-483.[ Price : $8.95]
Roxane Laboratories urges FDA to deny a Jazz Pharmaceuticals citizen petition seeking to block generic copies of Xyrem (sodium oxy...[ Price : $8.95]
Ventrus Biosciences says it will file an NDA for diltiazem hydrochloride cream for treating anal fissures in the fourth quarter ne...[ Price : $8.95]
FDAs Anti-Infective Drugs Advisory Committee votes in favor of GlaxoSmithKlines raxibacumab for treating inhalational anthrax.