Agios Sets February 2027 FDA Goal Date for Mitapivat in Sickle Cell Disease
Cambridge, Massachusetts — October 30, 2026 Agios Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has...
Accelerated Approval
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Invivyd Reports Positive Phase 3 LIBERTY Data for VYD2311
NEW HAVEN, Conn. — September 29, 202 Invivyd announced topline results from the Phase 3 LIBERTY study evaluating VYD2311,...
uniQure Reports 48-Month AMT-130 Data in Huntington’s Disease
LEXINGTON, Mass. and AMSTERDAM September 29, 2026 — uniQure N.V. announced additional data from ongoing Phase 1/2 studies of...
Cellectar Reports Iopofosine I 131 Data in BTKi-Refractory Waldenström Macroglobulinemia
FLORHAM PARK, N.J. — September 29, 2026 Cellectar Biosciences announced that a subset analysis from the Phase 2 CLOVER-WaM...
Acadia Gains U.S. Patent Allowance for Trofinetide Dosing
SAN DIEGO — September 29, 2026 Acadia Pharmaceuticals Inc. announced that the U.S. Patent and Trademark Office (USPTO) has...
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Verastem Reports Two-Year RAMP 201 Data in LGSOC
BOSTON — September 28, 2026 Verastem Oncology announced the publication in Gynecologic Oncology of two-year follow-up data from the...
BMS Reports EXCALIBER-RRMM Results for ZENBEXUS
PRINCETON, N.J. — September 26, 2026 Bristol Myers Squibb announced the first presentation of results from the pivotal Phase...
Rocket Pharmaceuticals Advances RP-A501 Toward Danon Disease Approval
CRANBURY, N.J. — September 15, 2026 Rocket Pharmaceuticals, Inc. announced alignment with the U.S. Food and Drug Administration (FDA)...
Bayer Wins FDA Accelerated Approval for Sevabertinib
BERLIN — September 9, 2026 Bayer announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval...
FDA Grants Accelerated Approval to Etcamah for Breast Cancer
Silver Spring, Maryland, USA, September 4, 2026 The U.S. Food and Drug Administration (FDA) has granted accelerated approval to...
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