FDA grants fast-track designation to posdinemab, an investigational J&J Alzheimers drug.
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FDA publishes a draft guidance on developing drugs for optical imaging for three purposes.
FDA accepts for priority review a Dizal NDA for sunvozertinib, an oral EGFR inhibitor for treating locally advanced or metastatic non-small cell lung ...
FDA warns Indias Indoco Remedies about repeat CGMP violations in its production of finished drugs.
