FDA issues an update on a Philips Respironics device correction involving its Trilogy Evo platform ventilators, citing risks that could cause serious ...
FDA extends by three months its review timeline of a Beren Therapeutics NDA for adrabetadex for treating infantile-onset Niemann-Pick disease, Type C.
FDA approves AstraZenecas Imfinzi (durvalumab) in combination with Bacillus Calmette-Guerin (BCG) for treating adults with BCG-nave, high-risk non-mus...
BrainStorm Cell Therapeutics names former FDA associate commissioner Peter Pitts to its board of directors.
An FDA advisory committee recommends updating Covid-19 vaccines for the 2026-2027 immunization season to target the currently dominant XFG variant.
FDA warns Alsip, IL-based GC America about CGMP violations in its production of finished drugs.
FDA extends its review of an AstraZeneca NDA for camizestrant, an experimental breast cancer therapy, after requesting additional data tied to a close...
Corcept Therapeutics plans to resubmit its NDA for relacorilant as a treatment for patients with Cushings syndrome, following additional analyses requ...
