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.
Researchers say manufacturers could make better use of predetermined change control plans for AI-enabled medical devices.
A Cooley legal analysis notes that FDA and federal prosecutors are signaling a tougher stance on failures to report patient safety issues to regulator...
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.
