accelerated approval

opening door to brick wall
Biotech

Senate hearing takes aim at FDA's rare disease review process

“The members of the panel were like talking to a brick wall,” Jeremy Schmahmann, M.D., testified about his experience at three FDA panels.
Gabrielle Masson Feb 26, 2026 3:50pm
FDA

FDA outlines draft policy on MRD for accelerated approval

Jan 21, 2026 2:55pm
sarepta building
Favicon Fierce Pharma

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

Nov 4, 2025 7:56am
Stock decreasing graphic

Applied Tx's stock drops on non-update for rare disease asset

Sep 29, 2025 10:57am
road through forest
Favicon Fierce Pharma

Stealth scores FDA approval for 1st Barth syndrome treatment

Sep 19, 2025 6:00pm
image of two race cars neck and neck

Daiichi, Merck rev up for accelerated approval filing

Sep 7, 2025 10:45am