Federal Register notice: FDA makes available a draft guidance entitled Infectious Otitis Externa Drugs for Topical Use in Dogs.
FDA finds deficiencies in Ascendis Pharmas NDA for TransCon PTH (palopegteriparatide), indicated for treating hypoparathyroidism.
Federal Register notice: FDA makes available a draft guidance entitled Marketing Submission Recommendations for a Predetermined Change Control Plan fo...
A JAMA research letter says 54% of accelerated approval-related confirmatory studies conducted between 2012 and 2021 were late in meeting their FDA co...
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 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...
