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Drug Approval

Mifepristone Compounding Pharmacies Medical Ethics Safety Concerns cGMP Compliance Safety Warnings Donanemab Pharmaceutical Regulations

Missouri, Kansas and Idaho Sue to Block FDA’s New Generic Mifepristone Approval, Curb Mail-Order Access

The filing escalates a state-led effort to roll back FDA decisions that expanded remote access to medication abortion.

FDA Adds Boxed Warning to Elevidys, Narrows Use to Ambulatory Patients 4 and Older

FDA Ends GLP-1 Drug Shortages, Triggering New Pricing and Coverage Moves