accelerated approval

Pharma

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

Sarepta’s Vyondys 53 and Amondys 45 failed to show a statistically significant difference versus placebo on a key measurement of DMD patient mobility.

Angus Liu Nov 4, 2025 7:56am

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

Sep 25, 2025 12:37pm

Stealth scores FDA approval for 1st Barth syndrome treatment

Sep 19, 2025 6:00pm

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

Jul 18, 2025 1:32pm

ASCO: Pfizer's Braftovi combo slashes death risk in rare cancer

May 30, 2025 8:00am

Fierce Biotech

Stealth CEO questions FDA rejection of rare disease drug

May 29, 2025 2:27pm