Dizal Showcases its Strong Hematology Pipeline with New Data from Golidocitinib and Birelentinib at ASH 2025
SHANGHAI, Dec. 9, 2025 /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for cancer and immunological diseases, announced new data from its hematology portfolio at the 67th American Society of...
Hope Medicine Inc.'s HMI-115 Received U.S. FDA Fast Track Designation, Accelerating Global Development
HMI-115 received FDA Fast Track Designation based on results from a Phase II clinical trial for endometriosis Mean dysmenorrhea pain score reduced by 42% Mean non-menstrual chronic pelvic pain score reduced by 52% Most patients maintained normal...
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...
Alphamab Oncology Announces Biparatopic HER2-targeting ADC JSKN003 Was Granted Fast Track Designation by FDA for the Treatment of PROC
SUZHOU, China, Oct. 28, 2025 /PRNewswire/ -- Alphamab Oncology (stock code: 9966.HK) announced that the biparatopic HER2-targeting antibody-drug conjugate (ADC) JSKN003 has been granted Fast Track Designation (FTD) by 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...
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...
OnCusp Therapeutics Receives FDA Fast Track Designation for CUSP06 for the Treatment of Platinum-Resistant Ovarian Cancer
PRINCETON, N.J., Feb. 12, 2025 /PRNewswire/ -- OnCusp Therapeutics, Inc., a clinical stage biopharmaceutical company dedicated to transforming cutting-edge preclinical innovation into clinically validated treatments for cancer patients, today...