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Review Extended on Agios sNDA for Sickle Cell Drug
FDA has extended by three months its review of an Agios Pharmaceuticals supplemental NDA for mitapivat, an oral pyruvate kinase (PK) activator, for treating sickle cell disease. The user fee review action target date is now 2/1/2027. The company says FDA recently requested additional information to evaluate whether
FDA Removes More Estrogen Patch Boxed Warnings
FDA has approved revised labeling for three additional estradiol transdermal patch products, removing boxed-warning statements about cardiovascular disease, breast cancer and probable dementia, HHS announced 10/30, prompting renewed criticism over the agency's decision to proceed without a formal advisory committee meeting or publicly presenting detailed scientific
AMA Urges FDA to Uphold ‘Rigorous Standards’ for Botanicals
The American Medical Association (AMA) is urging FDA to “uphold rigorous, evidence-based standards for evaluating botanical drug products,” warning that products marketed with unproven health claims can pose serious risks when their safety and efficacy have not been established. In comments to FDA, the AMA emphasized that botanical products
CBER Warns Against Unsupported Survival Claims in Biologic Promotions
CBER’s Advertising and Promotional Labeling Branch (APLB) is warning biologic marketers against using progression-free survival and overall survival data from single-arm studies to support promotional claims that cannot be substantiated by the underlying clinical evidence. Speaking at a 10/28 Food and Drug Law Institute advertising and