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FDA Proposes ‘Plausible Mechanism’ Pathway for Individualized Rare-Disease Therapies

Sponsors would gain a route to approval based on plausible biology, with obligations to verify outcomes after launch.

FDA Eases CMC Rules for Cell and Gene Therapies to Speed Development

FDA Eases Oversight of Wearables and Clinical Decision Support in Final Guidance

FDA Creates 'Green List' for GLP-1 Ingredients as WHO Names the Drugs Essential

FDA Brings Back Vinay Prasad to Lead Biologics Unit After Brief Exit

FDA Investigates Fatal Liver Failures Linked to Sarepta’s Elevidys Therapy