BridgeBio to Present New Infigratinib Data in Achondroplasia
PALO ALTO, Calif., September 2, 2026 BridgeBio Pharma, Inc. announced plans to present new clinical data on the impact...
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uniQure Submits BLA for AMT-130 in Huntington’s Disease
LEXINGTON, Mass. and AMSTERDAM, September 2, 2026 uniQure N.V. announced the submission of a Biologics License Application (BLA) to...
Daiichi Sankyo, AstraZeneca Advance Datroway in Phase 3 Urothelial Cancer Trial
Tokyo, August 26, 2026 Daiichi Sankyo announced that the first patient has been dosed in TROPION-Urothelial04, a global Phase...
INmune Bio Advances Ebstrocel Toward EU Marketing Filing
BOCA RATON, Fla., Aug. 26, 2026 INmune Bio Inc. has advanced Ebstrocel™ toward potential European commercialization after submitting two...
Pfizer and Valneva Secure EMA Validation for Lyme Vaccine
NEW YORK and LYON, France, August 14, 2026 Pfizer Inc. and Valneva SE announced that the European Medicines Agency...
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Scholar Rock Advances Apitegromab FDA Review with Second Fill-Finish Facility
CAMBRIDGE, Mass., August 7, 2026 Scholar Rock announced that the U.S. Food and Drug Administration (FDA) review of its...
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...
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...
AnHorn Medicines Advances AH-008 into Phase I Trial for CIPN Prevention
Irvine, California, USA — July 27, 2026 July 27, 2026 – AnHorn Medicines has announced the successful first subject...
Zevra Therapeutics to Seek EU Re-Examination for Arimoclomol After CHMP Opinion
BOSTON – July 24, 2026 Zevra Therapeutics, Inc. has announced that the European Medicines Agency’s (EMA) Committee for Medicinal...
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