A CDER drug approval reports shows that first-cycle NDA approvals fell in 2024 to 74% (37 of the 50 novel drugs approved) from 84% (46 of the 55 novel...
FDA asks members of its Anesthetic and Analgesic Drug Products Advisory Committee to discuss several challenges the agency has identified in a BLA for...
Vanda Pharmaceuticals criticizes FDA for failing to approve the companys NDA for tradipitant to treat the symptoms of gastroparesis.
Annes Daye says it is pulling its CBD-coated tampons from the U.S. market following receipt of an FDA Warning Letter.
FDA warns Indias Indoco Remedies about repeat CGMP violations in its production of finished drugs.
FDA publishes a draft guidance with recommendations on clinical trials for drugs and biologics to treat obesity and overweight.
FDA issues a guidance finalizing a 2023 draft document on communicating scientific information on unapproved uses of approved or cleared medical produ...
Johnson & Johnson says its Phase 3 MARIPOSA study showed that its Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) had a statistically signific...
