FDA outlines research into potential pharmacodynamic biomarkers for biosimilar development.
Federal Register notice: FDA establishes a docket to obtain information and comments to help assess whether in-home disposal products can be expected ...
CBER director Peter Marks says Covid-19 vaccine makers will be given advice in June on the next booster vaccine composition for fall injections.
Phathom Pharmaceuticals says it will resubmit an NDA for vonoprazan for treating erosive esophagitis, and a post-approval supplement for Voquezna Trip...
FDA accepts for review two Pfizer Supplemental NDAs for Braftovi (encorafenib) and Mektovi (binimetinib) and their use in patients with metastatic non...
CDER issues an updated MAPP for Office of Clinical Pharmacology IND review processes.
FDA posts a draft guidance entitled Human User Safety in New and Abbreviated New Animal Drug Applications to inform sponsors of the types of informati...
Abbott issues a safety notice for the Readers and batteries used as part of the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash g...
