Tag: fda

Ofirnoflast (HT-6184) Receives Orphan Drug Designation from U.S. FDA for Myelodysplastic Syndromes

LEHI, Utah, Oct. 23, 2025 /PRNewswire/ -- Halia Therapeutics, Inc., a clinical-stage biopharmaceutical…

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Domp’s Program in NAION Selected for Landmark FDA Commissioners National Priority Voucher Program

One of just nine voucher recipients chosen and the only one in…

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Revolution Medicines Awarded Voucher for Daraxonrasib (RMC-6236) Under FDA Commissioner’s National Priority Voucher Pilot Program

REDWOOD CITY, Calif., Oct. 16, 2025 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc.…

GlobeNews Wire

Berlin Heals Holding AG Successfully Completes Enrollment in Phase I of the CMIC-III Less Invasive Study

Completed Enrollment in First-In-Human Phase I study of Less Invasive Approach Expected…

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Glac Biotech Secures U.S. Food and Drug Administration GRAS Approval for Probiotic Strain CP-9

TAIPEI, Sept. 15, 2025 /PRNewswire/ -- Glac Biotech, a Taiwan-based developer of…

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Novo Nordisk A/S: Wegovy approved in the US for the treatment of MASH

Bagsværd, Denmark, 15 August 2025 – Novo Nordisk today announced that the US…

GlobeNews Wire

Regen BioPharma Discusses Potential Impact of HemaXellerate on Chemotherapy Treament Market

SAN DIEGO, Aug. 15, 2025 (GLOBE NEWSWIRE) -- Regen BioPharma, Inc. (OTC…

GlobeNews Wire

Anbogen Receives FDA Clearance to Initiate Phase 1/2 Trial of ABT-301 Triplet Therapy for Advanced Colorectal Cancer

TAIPEI, Aug. 4, 2025 /PRNewswire/ -- Anbogen Therapeutics today announced that the…

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