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 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 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 […]
Co-Diagnostics, Inc. Announces Intention to Submit Enhanced Version of COVID-19 Test to FDA for 510(k) Clearance
The Company is withdrawing current submission based on FDA feedback related to shelf-life stability of a test component SALT LAKE CITY, Feb. 21, 2025 /PRNewswire/ — Co-Diagnostics, Inc. (Nasdaq-CM: CODX) (the “Company” or “Co-Dx”), a […]