mucosal melanoma Archives | Be Korea-savvy
FDA Grants Toripalimab Fast Track Designation for Mucosal Melanoma

FDA Grants Toripalimab Fast Track Designation for Mucosal Melanoma

SHANGHAI, China, Jan. 25 (Korea Bizwire) — Junshi Biosciences (HKEX: 1877; SSE: 688180), an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that U.S. Food and Drug Administration (FDA) has granted toripalimab Fast Track designation for the first-line treatment of mucosal melanoma. Meanwhile, the FDA has also approved [...]

Junshi Biosciences Receives Orphan Drug Designation from the U.S. FDA for Toripalimab in Combination with Pfizer’s Axitinib for the Treatment of Mucosal Melanoma

Junshi Biosciences Receives Orphan Drug Designation from the U.S. FDA for Toripalimab in Combination with Pfizer’s Axitinib for the Treatment of Mucosal Melanoma

SHANGHAI, China, March 30 (Korea Bizwire) — Junshi Biosciences (HKEX: 1877) today announced that the U.S. Food and Drug Administration (FDA) has recently granted Orphan Drug Designation (ODD) for toripalimab in combination with Pfizer’s axitinib for the treatment of patients with mucosal melanoma. Toripalimab is an anti-PD-1 monoclonal antibody developed by Junshi. Toripalimab received its [...]