Savara MOLBREEVI MAA Accepted by UK MHRA for PAP
Langhorne, Pennsylvania, USA, April 7, 2026 MHRA Acceptance Marks Key Regulatory Milestone In a significant advancement for rare disease...
FDA Priority Review
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Praxis Precision Medicines Gains FDA Priority Review Boost
BOSTON, March 30, 2026 Praxis Precision Medicines has achieved a major regulatory milestone as the U.S. Food and Drug...
Ionis Zilganersen NDA Gets FDA Priority Review
CARLSBAD, California, March 23, 2026 Ionis Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has accepted...
FDA Priority Review Granted to Garetosmab for FOP
Rare Disease Biologic Advances Toward U.S. Approval – February 19, 2026 | Tarrytown, New York Regeneron Pharmaceuticals announced that...
FDA Accepts LEQEMBI sBLA, Expanding At-Home Alzheimer’s Therapy
Tokyo & Cambridge, Massachusetts, January 25, 2026 — Eisai Co., Ltd. and Biogen Inc. announced that the U.S. Food...
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