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- FDA gives rejected drugs another chance in post-Makary eraDid you receive a complete response letter in the past year? Now may be the time for a resubmission. In the wake of FDA Commissioner Marty Makary's departure last month, the agency has already agre…Endpoints · 1mo ago↗ source
- FDA warns telehealth companies over compounded GLP-1sThe FDA has issued a new batch of warning letters to 25 telehealth companies, accusing them of making false and misleading claims in their marketing of compounded GLP-1 weight loss drugs. The lette…Endpoints · 1mo ago↗ source
- UniQure to file gene therapy for approval, reflecting major shifts at FDAThe decision marks another regulatory U-turn following the exits of Marty Makary and Vinay Prasad, suggesting to some analysts that current FDA leadership may be more flexible in certain cases.