CDER Office of Prescription Drug Promotion researchers say disclosing methodological rigor in communications to healthcare providers may help them for...
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...
