Zymedi Announces "rapaprutug" as the International Nonproprietary Name (INN) for ZMA001
INCHEON, South Korea, Dec. 8, 2025 /PRNewswire/ -- Zymedi (CEO Sunghoon Kim) announced that the World Health Organization (WHO) has assigned rapaprutug as the International Nonproprietary Name (INN) for the company's first-in-class antibody therapy...
INCLUSION OF TINENGOTINIB TABLETS IN THE LIST OF PRODUCTS FOR PRIORITY REVIEW BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION
NANJING, China and GAITHERSBURG, Md., Dec. 4, 2025 /PRNewswire/ -- TransThera Sciences Nanjing, Inc. (the "TransThera") announced that Tinengotinib tablets have been included in the List of Products for Priority Review by the Center for Drug...
LISCure Biosciences Initiates Global Phase 2 Trial of LB-P8 in Primary Sclerosing Cholangitis (PSC)
SEOUL, South Korea, Nov. 10, 2025 /PRNewswire/ -- LISCure Biosciences ("LISCure"), a clinical-stage biopharmaceutical company, announced the initiation of patient dosing in a global Phase 2 clinical trial of LB-P8, a novel therapeutic candidate for...
Ribo Granted EMA Orphan Drug Designation for siRNA Therapeutic RBD1016 for Hepatitis Delta Virus (HDV) Infection
BEIJING and GOTHENBURG, Sweden, Oct. 24, 2025 /PRNewswire/ -- Suzhou Ribo Life Science Co., Ltd. and Ribocure Pharmaceuticals AB (Ribo), today announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to RBD1016...
Ofirnoflast (HT-6184) Receives Orphan Drug Designation from U.S. FDA for Myelodysplastic Syndromes
LEHI, Utah, Oct. 23, 2025 /PRNewswire/ -- Halia Therapeutics, Inc., a clinical-stage biopharmaceutical company pioneering therapies that target the root causes of inflammation-driven diseases, today announced that the U.S. Food and Drug...
FDA Grants Fast Track Designation for AJ201, a First-in-Class Therapy for Kenndy's Disease
TAIPEI, Oct. 23, 2025 /PRNewswire/ -- AnnJi Pharmaceutical Co., Ltd. (AnnJi, TWSE: 7754) today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track Designation for AJ201, the first-in-class for therapy for spinal and...
RemeGen's Telitacicept (RC18) Received Orphan Drug Designation from EMA for Myasthenia Gravis
YANTAI, China, June 17, 2025 /PRNewswire/ -- On June 16, 2025, RemeGen Co., Ltd. ("RemeGen", stock symbols: 688331.SH/09995.HK) announced that telitacicept (RC18; brand name: 泰爱®) has received Orphan Drug Designation (ODD) from European Medicines...
IASO Bio Receives Orphan Drug Designation from the Saudi Food and Drug Authority for Equecabtagene Autoleucel
SHANGHAI, NANJING, China and SAN FRANCISCO, May 9, 2025 /PRNewswire/ -- IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of innovative cell therapies and...
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...