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FDA extends its review of an AstraZeneca NDA for camizestrant, an experimental breast cancer therapy, after requesting additional ...[ Price : $8.95]
Corcept Therapeutics plans to resubmit its NDA for relacorilant as a treatment for patients with Cushings syndrome, following addi...[ Price : $8.95]
FDA approves an AbbVie NDA for Decnupaz (pivekimab sunirine-pvzy) and its use in treating adults with blastic plasmacytoid dendrit...[ Price : $8.95]
NSF consultants report on a webinar discussing the best practices in responding to inspection observations in a form FDA-483.[ Price : $8.95]
FDA warns Indias Alchymars ICM SM Private Limited about CGMP deviations in its production of active pharmaceutical ingredients.[ Price : $8.95]
FDA warns Japans Sato Pharmaceutical Co. about CGMP violations in its production of finished over-the-counter drugs.[ Price : $8.95]
The U.S. government urges the Supreme Court to reject an appeal by a Texas compounding pharmacy in a closely watched case over whe...[ Price : $8.95]
Outlook Therapeutics wins an appeal with FDA over its BLA for ONS-5010/Lytenava (bevacizumab-vikg), clearing a potential path towa...