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...
FDA approves an AbbVie NDA for Decnupaz (pivekimab sunirine-pvzy) and its use in treating adults with blastic plasmacytoid dendritic cell neoplasm.
NSF consultants report on a webinar discussing the best practices in responding to inspection observations in a form FDA-483.
