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 company pioneering therapies that target the root causes…

2 weeks ago

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 the eye space, the selection spotlights Dompé’s dedication…

3 weeks ago

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. (Nasdaq: RVMD), a late-stage clinical oncology company developing…

3 weeks ago

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 to Present 6-Month data in 2026 at a…

4 weeks ago

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 probiotics and postbiotics, announced that its core probiotic…

2 months ago

U.S. FDA Approves Expanded Indication for VONVENDI [von Willebrand factor (Recombinant)] for Adults and Children with Von Willebrand Disease

− Approval Expands Use of VONVENDI to Include Routine Prophylaxis to Reduce the Frequency of Bleeding Episodes in Adults with…

2 months ago

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 Food and Drug Administration (FDA) has approved an…

3 months ago

Regen BioPharma Discusses Potential Impact of HemaXellerate on Chemotherapy Treament Market

SAN DIEGO, Aug. 15, 2025 (GLOBE NEWSWIRE) -- Regen BioPharma, Inc. (OTC ID: RGBP and RGBPP) today provided further insight…

3 months ago

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 U.S. Food and Drug Administration (FDA) has approved…

3 months ago

Valneva Announces Removal of FDA-Recommended Pause on Use of Chikungunya Vaccine IXCHIQ in Elderly and Updates to the Prescribing Information

Saint Herblain (France), August 7, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced…

3 months ago