FDA

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Biotech

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

All the figurative FDA trains are running on time, according to the agency’s leader Marty Makary, M.D.

Gabrielle Masson Jun 18, 2025 4:00am

Magnifying glass with pills on blue

FDA debuts priority review voucher with 2-month timeline goal

Jun 17, 2025 11:59am

FDA

Dexcom replaces handheld CGM receivers after missed audio alerts

Jun 17, 2025 10:40am

Gilead

FDA slaps clinical hold on multiple Gilead HIV trials

Jun 10, 2025 10:48am

FDA

FDA clears Reflow Medical’s retrievable below-the-knee stent

Jun 9, 2025 11:00am

oncology cancer test mammogram mammography breast cancer

FDA clears Clairity's 5-year breast cancer risk prediction tool

Jun 5, 2025 1:00pm