FDA

Martin Makary FDA Senate HELP confirmation

Biotech

FDA reveals 2nd round of 'national priority' voucher winners

The program is designed to cut the agency's typical 10- to 12-month review timeline down to just one or two months.

Darren Incorvaia Nov 6, 2025 3:12pm

Graphic image of a red thumbs down against a blue background

FDA rejects Biohaven approval request, triggering cost cutting

Nov 5, 2025 4:02am

X-ray of lungs

Olympus updates corrective action related to 2023 lung scope recall

Nov 4, 2025 8:00am

sarepta building

Fierce Pharma

Sarepta, despite key trial flop, will seek full nod for DMD meds

Nov 4, 2025 7:56am

uturn

uniQure's gene therapy for Huntington's hits FDA roadblock

Nov 3, 2025 10:03am

purple lightning tornado

Electra shines with $183M fundraise for rare disease trial

Oct 22, 2025 8:26am