AccurEdit Therapeutics' LNP-based In Vivo Gene Editing Product ART001 Obtained Orphan Drug Designation from the FDA
CAMBRIDGE, Mass., March 25, 2025 /PRNewswire/ -- AccurEdit Therapeutics today announced that its innovative in vivo gene editing product, ART001, has obtained Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA). ART001,...
Henlius Receives Orphan Drug Designation for Innovative Anti-HER2 mAb HLX22 in the U.S. for Gastric Cancer
SHANGHAI, March 19, 2025 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for HLX22, the company's innovative anti-HER2 monoclonal antibody...
HanAll Biopharma Announces Orphan Drug Designation for Batoclimab in Japan for Active Thyroid Eye Disease
Batoclimab receives Orphan Drug Designation in Japan, advancing treatment for active Thyroid Eye Disease (TED). Batoclimab, subcutaneous formulation, offers the potential for at-home administration, improving patient convenience and accessibility....
FDA Grants Orphan Drug Designation to MicuRx's MRX-5 for NTM Infections
SHANGHAI, Jan. 2, 2025 /PRNewswire/ -- Shanghai MicuRx Pharmaceutical Co., Ltd. ("MicuRx"，688373.SH) announced that MRX-5, its self-developed anti-infection drug, has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug...
FDA Granted Orphan Drug Designation of LBL-024, An Anti-PD-L1/4-1BB Bispecific Antibody Developed by Leads Biolabs, for Treatment of Neuroendocrine Cancer
NANJING, China, Nov. 22, 2024 /PRNewswire/ -- Nanjing Leads Biolabs Co., Ltd. (hereinafter referred to as "Leads Biolabs") announced that LBL-024, an anti-PD-L1/4-1BB bispecific antibody independently developed by the company with global...