accelerated approval

opening door to brick wall
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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
U-turn pivot about-face

Atara, Pierre Fabre receive 2nd US rejection for Ebvallo

Jan 12, 2026 11:30am
sarepta building

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

Nov 4, 2025 7:56am
Doctor holding diagram of kidneys

Hansa eyes FDA filing after ph. 3 win for kidney transplant med

Sep 25, 2025 12:37pm
road through forest

Stealth scores FDA approval for 1st Barth syndrome treatment

Sep 19, 2025 6:00pm
Genentech

FDA rejects Roche's earlier DLBCL bid over lackluster US data

Jul 18, 2025 1:32pm