Global Development Accelerates: Leads Biolabs' PD-L1/4-1BB Bispecific Antibody Granted Fast Track Designation by FDA

January 15, 2026) - Nanjing Leads Biolabs Co., Ltd. (HKE: 9887) ("Leads Biolabs" or the "Company") today announced that Opamtistomig (LBL-024), its core investigational PD-L1/4-1BB bispecific antibody ...

Encoded Therapeutics Announces U.S. FDA Breakthrough Therapy Designation Granted to ETX101 for the Treatment of Dravet Syndrome

Encoded Therapeutics, Inc. ("Encoded"), a clinical-stage biotechnology company developing precision genetic medicines for severe neurological disorders, today announced that the U.S. Food and Drug ...

Protara Therapeutics Receives Both FDA Breakthrough Therapy and Fast Track Designations for TARA-002 in Pediatric Patients with Lymphatic Malformations

Receiving these important FDA designations and invitation to participate in the CDRP program highlights the significant unmet need among pediatric patients with LMs and underscores our belief that ...
Seeking Alpha

Creative Medical Technology Holdings Secures FDA Fast Track Designation for CELZ-201-DDT - Advancing Breakthrough Therapy for Chronic Lower Back Pain

PHOENIX, Aug. 13, 2025 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (CELZ), a clinical-stage biotechnology company focused on regenerative and immune cellular therapies, today ...

Protara, CeriBell rise on FDA breakthrough designations

Protara Therapeutics stock (TARA) and CeriBell stock (CBLL) gain as the FDA issues breakthrough designations for their ...
MyCentralJersey

Rusfertide Receives Breakthrough Therapy Designation for Treatment of Erythrocytosis in Patients with Polycythemia Vera

Breakthrough designation for rusfertide was supported by positive 32-week data from the Phase 3 VERIFY study, which was presented as a late breaking abstract highlighting its practice-changing ...