FDA extends its review of an AstraZeneca NDA for camizestrant, an experimental breast cancer therapy, after requesting additional data tied to a close...
Corcept Therapeutics plans to resubmit its NDA for relacorilant as a treatment for patients with Cushings syndrome, following additional analyses requ...
FDA approves an AbbVie NDA for Decnupaz (pivekimab sunirine-pvzy) and its use in treating adults with blastic plasmacytoid dendritic cell neoplasm.
NSF consultants report on a webinar discussing the best practices in responding to inspection observations in a form FDA-483.
FDA warns Indias Alchymars ICM SM Private Limited about CGMP deviations in its production of active pharmaceutical ingredients.
FDA warns Japans Sato Pharmaceutical Co. about CGMP violations in its production of finished over-the-counter drugs.
The U.S. government urges the Supreme Court to reject an appeal by a Texas compounding pharmacy in a closely watched case over whether federal drug la...
Outlook Therapeutics wins an appeal with FDA over its BLA for ONS-5010/Lytenava (bevacizumab-vikg), clearing a potential path toward U.S. approval of ...
