The BioCharge implant is the first-of-its-kind fully resorbable synthetic scaffold designed to supercharge tendon healing with a significantly simplified surgical technique DUBLIN, Ohio, Feb. 20, 2025 /PRNewswire/ — Atreon Orthopedics, LLC, a Columbus based innovator in […]
Tag: FDA Approval
Clarity receives US FDA Fast Track Designation for the treatment of metastatic castration-resistant prostate cancer patients with Cu-67 SAR-bisPSMA
SYDNEY, Feb. 19, 2025 /PRNewswire/ — Clarity Pharmaceuticals (ASX: CU6) (“Clarity” or “Company”), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, is […]
U.S. FDA approves Celltrion’s AVTOZMA® (tocilizumab-anoh), a biosimilar to ACTEMRA®
AVTOZMA® will be available as both intravenous (IV) and subcutaneous (SC) formulations with the same formulations and dosages as the reference product Approval was received for multiple indications, including rheumatoid arthritis (RA), giant cell arteritis (GCA), […]
Incyte and Syndax Announce U.S. Food and Drug Administration (FDA) Approval of Niktimvo™ (axatilimab-csfr) 9 mg and 22 mg Vial Sizes
– U.S. launch expected in early February – – Niktimvo is the first and only approved treatment for chronic GVHD that targets CSF-1R to reduce the drivers of inflammation and fibrosis – – Pivotal data […]
Neurocrine Biosciences Announces FDA Approval of CRENESSITY™ (crinecerfont), a First-in-Class Treatment for Children and Adults With Classic Congenital Adrenal Hyperplasia
CRENESSITY, the first new treatment available in 70 years to the classic congenital adrenal hyperplasia (CAH) community, offers a paradigm-shifting treatment approach FDA approval supported by data from the largest-ever clinical trial program in pediatric […]











