FDA approves a Bristol Myers Squibb and 2Seventy Bio supplemental BLA for Abecma (idecabtagene vicleucel; ide-cel) for treating certain adult patients...
Honeywell Safety Products recalls its Fendall 2000 Non-Sterile Eyewash Cartridge for the Fendall 2000 Eyewash Station due to GMP concerns.
FDA grants Daiichi Sankyo an accelerated approval for Enhertu (fam-trastuzumab deruxtecan-nxki) for treating certain adult patients with unresectable ...
FDA issues Jubilant Generics a four-observation Form FDA-483 after inspecting the firms India facility in February.
AbbVie petitions FDA urging it to crack down on newly introduced unlicensed desiccated thyroid extract products.
Federal Register notice: FDA seeks industry organizations interested in participating in selecting a nonvoting industry representative to serve on CDR...
Federal Register notice: FDA announces a 5/22 Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee meeting to discuss requirement...
Some 31 experts in genetics, addiction, psychiatry, and medical devices call on FDA to revoke its approval of the AvertD DNA test that claims to predi...
