FDA approves ViiV Healthcares Dovato (dolutegravir/lamivudine) for treating HIV-1 infection in adolescents with no antiretroviral treatment history or...
FDA accepts for review a Stealth BioTherapeutics NDA for elamipretide for treating Barth syndrome.
Federal Register notice: FDA issues an order to debar for five years Robert Lance Shuffert from importing or offering for import any drug into the U.S...
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.
