Praxis Precision Medicines Extends FDA Review for Relutrigine NDA
BOSTON, June 29, 2026 Praxis Precision Medicines announced that the U.S. Food and Drug Administration (FDA) has extended the...
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Capricor Reaches Key FDA Milestone in DMD
SAN DIEGO, June 26, 2026 Capricor Therapeutics announced that the U.S. Food and Drug Administration (FDA) has scheduled a...
Otsuka Reports Positive Phase 3b Results for Centanafadine
TOKYO, Japan & PRINCETON, N.J., June 26, 2026 Otsuka Pharmaceutical Co., Ltd. and Otsuka Pharmaceutical Development & Commercialization, Inc....
Moderna Gains FDA Panel Support for mRNA-1010 Flu Vaccine
CAMBRIDGE, Mass., June 20, 2026 Moderna, Inc. announced a major regulatory milestone for its investigational seasonal influenza vaccine mRNA-1010...
SK Life Science NDA for Cenobamate Suspension Accepted
PARAMUS, N.J., June 15, 2026 SK Life Science, Inc. has announced that the U.S. Food and Drug Administration (FDA)...
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Vertex FDA Accepts Povetacicept BLA for IgA Nephropathy
BOSTON, June 1, 2026 Vertex Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics...
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...
ImmunityBio’s ANKTIVA Expansion Review Accepted by FDA
CULVER CITY, Calif., May 19, 2026 ImmunityBio announced that the U.S. Food and Drug Administration (FDA) has accepted its...
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...
Savara Inc. Gets FDA Extension for Molgramostim Review
LANGHORNE, Pa., April 15, 2026 Savara Inc., a clinical-stage biopharmaceutical company focused on rare respiratory diseases, announced that the...
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