An FDA inspection last month at Alkem Laboratories India manufacturing facility leads to a 10-observation Form FDA-483.
A federal court approves an FDA-brokered consent decree against Philips Respironics over its defective breathing devices.
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.
FDA clears a Spirair 510(k) for its SeptAlign system for treating nasal septal deviation.
FDA approves a supplemental BLA submitted by Janssen for Carvykti (ciltacabtagene autoleucel) to treat adults with relapsed or refractory myeloma who ...
FDA sends Supernus Pharmaceuticals a second complete response letter on its NDA resubmission for the companys apomorphine infusion device (SPN-830) fo...
Federal Register notice: FDA requests nominations for voting members, excluding consumer and industry representatives, to serve on CDRHs Patient Engag...
