Pharmaceutical Technology on MSN

FDA grants Novartis’ ianalumab breakthrough therapy status for Sjögren’s disease

Novartis has announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to ...

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

Detailed price information for Artara Therapeutics Inc (TARA-Q) from The Globe and Mail including charting and trades.

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 ...
Zacks Investment Research on MSN

Novartis' ianalumab wins breakthrough therapy tag for Sjogren's disease

Novartis NVS announced that the FDA granted Breakthrough Therapy designation to its pipeline candidate, ianalumab for the ...

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 ...
Morningstar

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. (NASDAQ: CELZ), a clinical-stage biotechnology company focused on regenerative and immune cellular therapies, ...

Novartis ianalumab receives FDA Breakthrough Therapy designation for Sjögren’s disease

Designation based on clinical evidence supporting potential of ianalumab in Sjögren’s disease, including phase III trials1Distinction expedites development and review of treatments for serious ...