Fresenius Kabi’s Vedolizumab Biosimilar Accepted for FDA and EMA Review
BAD HOMBURG, Germany, July 31, 2026 Fresenius Kabi, an operating company of Fresenius, announced that both the U.S. Food...
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Polpharma Biologics Secures FDA and EMA Review for PB016
ROTKREUZ, Switzerland, July 31, 2026 Polpharma Biologics International AG announced that the U.S. Food and Drug Administration (FDA) and...
Ascletis Reports ASC37 Shows Superior Weight Loss in Obesity Study
Hong Kong, July 27, 2026 Ascletis Pharma Inc. announced that its investigational ASC37, a next-generation GLP-1R/GIPR/GCGR triple peptide agonist,...
Dyne Therapeutics Advances DMD Program with FDA Acceptance
WALTHAM, Mass., July 20, 2026 Dyne Therapeutics, Inc. (Nasdaq: DYN) announced that the U.S. Food and Drug Administration (FDA)...
Avance Clinical Unveils Asia Growth Strategy at BIO Asia–Taiwan
TAIPEI, Taiwan | July 10, 2026 Avance Clinical, the Australian-headquartered global Contract Research Organization (CRO), has announced its participation...
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Leads Biolabs Secures Priority Review for Opamtistomig
NANJING, China | July 10, 2026 Nanjing Leads Biolabs Co., Ltd. has announced that the Center for Drug Evaluation...
Invivyd Receives FDA EUA Termination Notice for PEMGARDA
NEW HAVEN, Conn., July 6, 2026 Invivyd announced that the U.S. Food and Drug Administration (FDA) has issued a...
Opus Genetics Secures FDA Alignment for Phase 3 Trial
RESEARCH TRIANGLE PARK, N.C., July 6, 2026 Opus Genetics announced that the U.S. Food and Drug Administration (FDA) has...
DBV Technologies Works With FDA to Finalize VIASKIN Peanut BLA
CHÂTILLON, France, June 29, 2026 DBV Technologies announced an update on the Biologics License Application (BLA) for its investigational...
AbbVie Reports Positive Phase 3 Epcoritamab DLBCL Results
NORTH CHICAGO, Ill., June 29, 2026 AbbVie has announced positive topline results from the Phase 3 EPCORE® DLBCL-4 clinical...
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