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Federal Register notice: FDA makes available a draft guidance entitled Marketing Submission Recommendations for a Predetermined Change Control Plan fo...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 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...
