FDA approves an Astellas Pharma BLA for Padcev (enfortumab vedotin-ejfv) for use with Mercks Keytruda in certain patients with locally advanced or met...
FDA posts a final guidance entitled Identification of Medicinal Products Implementation and Use based on five ISO standards.
Federal Register notice: FDA sends to OMB an information collection revision entitled Prescription Drug Advertising.
A U.S. government amicus brief sides with the generic drug industry in a closely watched Supreme Court appeal of a skinny label case brought by GlaxoS...
Datascope recalls its Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps due to an internal communication loss that could cause an unexpected shu...
FDA issues a 14-page Form FDA-483 to Global Pharma Healthcare in Tamilnadu, India that cites significant GMP deficiencies with its drug manufacturing.
Senators Tina Smith (D-MN) and Mike Braun (R-IN) reintroduce bipartisan legislation that would prevent brand drug companies from seeking agreements wi...
Hutchmed Ltd. completes a rolling NDA submission for fruquintinib, described as a highly selective and potent oral inhibitor of VEGFR-1, -2 and -3 for...
