Ultragenyx and Kyowa Kirin say they will submit an sBLA for a new indication for their Crysvita in the first half of 2020.
A Reuters investigative report examines the way in which a federal court allowed Merck to keep some Propecia risk information secret during considerat...
Hospira recalls one lot of its bacteriostatic water for injection, USP, 30 mL, multi-dose vial due to sterilization concerns.
FDA moves to ban non-tobacco-flavored e-cigarettes at the urging of President Trump during a 9/11 White House meeting with acting commissioner Ned Sha...
FDA accepts for review a Puma Biotechnology supplemental NDA for Nerlynx (neratinib) in combination with capecitabine for treating patients with HER2-...
FDA grants Checkpoint Surgical a breakthrough device designation for the companys brief electrostimulation therapy system for nerve regeneration.
FDA warns Chinas Hangzhou Badi Daily Use Chemical Company about CGMP and other violations in its manufacturing of finished drugs.
FDA releases its latest batch of Warning Letters that includes Enprani Co., and Hangzhou Badi Daily Use Chemical.