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FDA Approval

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Agios’ Sickle Cell Pill Lifts Hemoglobin but Misses Pain-Crisis Goal in Phase 3

The mixed efficacy leaves mitapivat’s expansion prospects uncertain during an FDA review in beta thalassemia that targets a Dec. 7 decision.

FDA Approves Palsonify, First Once-Daily Oral Treatment for Acromegaly

Roivant’s Brepocitinib Succeeds in 52-Week Dermatomyositis Phase 3 as Companies Target 2026 FDA Filing