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 Springfield, MA-based physician Adnan Dahdul about Bioresearch Monitoring violations in his conduct of a clinical investigation.
FDA extends by 30 days the comment period on a request for information entitled AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program."...
Eli Lilly says it is acquiring three vaccine developers in deals worth up to $3.8 billion combined, expanding its push into infectious disease prevent...
FDA cites Dabur India Limited for significant manufacturing and data integrity violations at an over-the-counter drug manufacturing facility in India.
