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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 probiotics and postbiotics, announced that its core probiotic…

1 week 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…

3 weeks 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…

1 month 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…

1 month 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…

2 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…

2 months ago

Galapagos NV Announces U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to GLPG5101 for the Treatment of Relapsed/Refractory Mantle Cell Lymphoma

Mechelen, Belgium; August 6, 2025, 7:30 CET; regulated information – inside information – Galapagos NV (Euronext & NASDAQ: GLPG) today…

2 months ago

Leo Cancer Care Receives FDA 510(k) Clearance for Marie – A Revolutionary Upright Radiotherapy Platform

MIDDLETON, Wis., July 29, 2025 /PRNewswire/ -- Leo Cancer Care, a leader in upright radiotherapy solutions, today announces that its flagship…

2 months ago

Zenara Pharma Receives U.S. FDA Approval for First Generic of Sertraline Hydrochloride Capsules with 180-Day CGT Exclusivity

HYDERABAD, India, August 1, 2025 /PRNewswire/ -- Zenara Pharma Private Limited ("Zenara"), a Biophore company, today announced that it has received final…

2 months ago

FDA Approves Apellis EMPAVELI (pegcetacoplan) as the First C3G and Primary IC-MPGN Treatment for Patients 12 and Older

Proven efficacy across all three key markers of disease—68% reduction in proteinuria, stabilization of kidney function, and substantial clearance of…

2 months ago