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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%...[ Price : $8.95]
FDA asks members of its Anesthetic and Analgesic Drug Products Advisory Committee to discuss several challenges the agency has ide...[ Price : $8.95]
Vanda Pharmaceuticals criticizes FDA for failing to approve the companys NDA for tradipitant to treat the symptoms of gastroparesi...[ Price : $8.95]
Annes Daye says it is pulling its CBD-coated tampons from the U.S. market following receipt of an FDA Warning Letter.[ Price : $8.95]
FDA warns Indias Indoco Remedies about repeat CGMP violations in its production of finished drugs.[ Price : $8.95]
FDA publishes a draft guidance with recommendations on clinical trials for drugs and biologics to treat obesity and overweight.[ Price : $8.95]
FDA issues a guidance finalizing a 2023 draft document on communicating scientific information on unapproved uses of approved or c...[ Price : $8.95]
Johnson & Johnson says its Phase 3 MARIPOSA study showed that its Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) had a st...