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accelerated approval
Pharma
Atara, Pierre Fabre receive 2nd US rejection for Ebvallo
Atara didn't hold back in criticizing the FDA's rationale, noting that the regulator’s new point of view runs “contrary to the FDA’s prior guidance."
Fraiser Kansteiner
Jan 12, 2026 11:30am
Sarepta, despite key trial flop, will seek full nod for DMD meds
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
