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Drug Approval

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