Marty Makary

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FDA shares more than 200 CRLs for now-approved drugs

All of the CRLs shared today are for drugs that have since gained approval from the agency, an HHS spokesperson told Fierce.
Gabrielle Masson Jul 10, 2025 10:54am
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Favicon Fierce Biotech

FDA 'on track' to meet all PDUFA dates, Marty Makary says

Jun 18, 2025 4:00am
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Favicon Fierce Biotech

FDA hopes AI can deliver 'rapid or instant' reviews

Jun 11, 2025 12:45pm
Marty Makary FDA Commissioner

Four states ask FDA to lift restrictions on mifepristone

Jun 6, 2025 8:21am
Senator Dick Durbin

Senator probes FDA drug ad regulation after OPDP cuts

May 30, 2025 10:10am
rare diseases
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Stealth CEO questions FDA rejection of rare disease drug

May 29, 2025 2:27pm