Food and Drug Administration (FDA)

FDA
Biotech

FDA gene therapy regulator steps down from leadership role

Acting CBER Director Karim Mikhail will oversee the Office of Therapeutic Products until a new permanent leader is found.
Darren Incorvaia Jun 30, 2026 10:36am
delay

Praxis faces FDA delay, analysts point finger at agency layoffs

Jun 30, 2026 4:13am
Kyle Diamantas

HHS unveils plan to speed up ph. 1 trials by 6 to 12 months

Jun 22, 2026 12:10pm
artificial intelligence concept with business analytics
Favicon Fierce Healthcare

HHS ramps up AI use cases, with most in pre-deployment: BPC

Jun 11, 2026 2:00pm
FDA

At CNPV hearing, industry support meets ‘concern’ from experts

Jun 5, 2026 5:00am
FDA stop sign

Fulcrum scraps SCD plan as FDA takes hard line on safety risks

Jun 2, 2026 8:46am