Cogent’s Bezuclastinib Gains FDA Priority Review for GIST
WALTHAM, Mass. and BOULDER, Colo., May 28, 2026 Cogent Biosciences has announced a major regulatory milestone with the U.S....
FDA Priority Review
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Sanofi’s Venglustat Gains FDA Priority Review for GD3
PARIS, France, May 28, 2026 Sanofi has achieved a major regulatory milestone with the U.S. Food and Drug Administration...
FDA Grants Priority Review to Zydus Therapeutics’ Saroglitazar for Rare Liver Disease
PENNINGTON, New Jersey and AHMEDABAD, India, May 28, 2026 Zydus Therapeutics, a wholly owned subsidiary of Zydus Lifesciences, has...
Bayer’s Asundexian Wins FDA Priority Review
BERLIN, Germany, May 19, 2026 Bayer has announced that the U.S. Food and Drug Administration (FDA) and Japan’s Ministry...
Curia Upgrades Spain API Suites for EU GMP Annex 1
ALBANY, N.Y., May 19, 2026 Curia Global, Inc. has announced the completion of a major upgrade to its aseptic...
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MEKanistic Clears FDA IND for MTX-531 Cancer Trial
MINNEAPOLIS, Minn., May 19, 2026 MEKanistic Therapeutics has announced that the U.S. Food and Drug Administration (FDA) cleared the...
Bayer’s Sevabertinib Gets FDA Priority Review
BERLIN, Germany, May 18, 2026 Bayer has announced that the U.S. Food and Drug Administration (FDA) granted Priority Review...
Eisai and Biogen Receive FDA Extension for LEQEMBI
TOKYO and CAMBRIDGE, Mass., May 8, 2026 Eisai Co., Ltd. and Biogen Inc. announced that the U.S. Food and...
BeOne Medicines Gains FDA Priority Review for TEVIMBRA
SAN CARLOS, CALIFORNIA, April 29, 2026 BeOne Medicines has announced that the U.S. Food and Drug Administration (FDA) has...
GSK Bepirovirsen Wins FDA Priority Review Breakthrough Status
LONDON, United Kingdom, April 28, 2026 GSK has announced that its investigational antisense oligonucleotide therapy bepirovirsen has been accepted...
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