SEATTLE, Sept. 19, 2025 /PRNewswire/ — HDT Bio Corporation, a U.S.-based clinical-stage biotechnology company advancing immune-enhancing solutions for global health, biodefense, and oncology, today announced that the U.S. Food and Drug Administration (FDA) has cleared […]
Tag: FDA Approval
FDA Grants Orphan Drug Designation to NS-051/NCNP-04 for the Treatment of Duchenne Muscular Dystrophy
PARAMUS, N.J., Sept. 19, 2025 /PRNewswire/ — NS Pharma, Inc. announced today that the U.S. Food & Drug Administration (FDA) has granted Orphan Drug Designation to NS-051/NCNP-04 which is being developed for the treatment of […]
FDA Approval of Leqembi Subcutaneous Formulation Charts Path to Combination Therapies for Alzheimer’s Disease
Subcutaneous delivery increases accessibility and introduces potential for at-homeadministration, following model of diabetes and GLP-1 drugs NEW YORK, Aug. 29, 2025 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) today announced its approval of […]
Foresee Pharmaceuticals Announces FDA Approval of CAMCEVI ETM for the Treatment of Advanced Prostate Cancer
TAIPEI, Aug. 28, 2025 /PRNewswire/ — Foresee Pharmaceuticals (6576.TWO), (“Foresee”) announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for CAMCEVI ETM (leuprolide mesylate 21 mg, ready-to-use […]
Innovent Biologics Announces U.S. FDA IND Approval for the First Global MRCT Phase 3 Study (MarsLight-11) of IBI363 (PD-1/IL-2α-bias) in Squamous Non-Small Cell Lung Cancer
SAN FRANCISCO and SUZHOU, China, Aug. 24, 2025 /PRNewswire/ — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company committed to developing, manufacturing and commercializing high-quality medicines in oncology, cardiovascular and metabolic diseases, autoimmune, […]










