FDA

Aardvark
Biotech

Aardvark to dig into phase 3 data early after FDA imposes hold

Aardvark Therapeutics is planning to unblind data from its phase 3 Prader-Willi syndrome program after the FDA put a full clinical hold on its trials.
Nick Paul Taylor May 15, 2026 1:51am
FDA
Favicon Fierce Pharma

Biopharma rallies behind Pazdur to lead FDA. But is he willing?

May 14, 2026 11:05am
Warren Biddle

Kyverna begins rolling FDA submission for autoimmune CAR-T in SPS

May 12, 2026 4:27pm
Martin Makary FDA Senate HELP confirmation
Favicon Fierce Pharma

FDA's embattled Marty Makary steps down as commissioner

May 12, 2026 2:30pm
Marty Makary FDA Commissioner
Favicon Fierce Pharma

Trump plans to end stormy 14-month tenure of FDA chief Makary

May 8, 2026 3:38pm
two arrows pointing different directions
Favicon Fierce Pharma

FDA to reconsider rejected cell therapy. Could uniQure be next?

May 7, 2026 10:40am