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
FDA stop sign
Favicon Fierce Pharma

FDA snubs Sobi’s gout drug over manufacturing issues

Jun 29, 2026 11:04am
The concept of treatment of the lungs of a patient infected with coronavirus

United Tx nabs FDA approval for donor-lung assessment device

Jun 29, 2026 9:27am
Whhop watch

FDA drops blood pressure device enforcement against Whoop

Jun 25, 2026 8:20am
FDA

FDA issues early alert for Abiomed device over bleeding risk

Jun 23, 2026 8:09am
Regenxbio

In another reversal, FDA to reconsider Regenxbio gene therapy

Jun 22, 2026 10:26am