Data from IDeate-Lung01 trial will be presented at upcoming IASLC 2025 World Conference on Lung Cancer First Breakthrough Therapy Designation for Daiichi Sankyo and Merck’s ifinatamab deruxtecan based ...
Breakthrough designation for rusfertide was supported by positive 32-week data from the Phase 3 VERIFY study, which was presented as a late breaking abstract highlighting its practice-changing ...
Zacks Investment Research on MSN
BIIB's next-gen SMA therapy Salanersen wins FDA's breakthrough tag
Biogen BIIB recently announced that the FDA has granted Breakthrough Therapy designation to Salanersen, an investigational ...
Pharmaceutical Technology on MSN
Biogen’s salanersen gains FDA breakthrough therapy designation for SMA
The FDA's decision follows data from a Phase Ib study on salanersen.
MARSEILLE, France--(BUSINESS WIRE)--Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) ...
SAN FRANCISCO and SUZHOU, China, May 10, 2026 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes ...
uniQure's AMT-130 receives Breakthrough Therapy designation from FDA for Huntington's disease, based on promising clinical trial data. uniQure N.V. announced that the U.S. FDA has granted Breakthrough ...
uniQure announces FDA's Breakthrough Therapy designation for AMT-130, with promising Phase I/II trial safety data and upcoming regulatory updates. uniQure N.V. has announced that its gene therapy ...
Litifilimab, a humanized immunoglobulin G1 monoclonal antibody that targets blood dendritic cell antigen 2, has been granted an FDA Breakthrough Therapy Designation, according to an announcement from ...
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