MPR

Molecular Glue Degrader TRI-611 Receives FDA Fast Track for ALK+ NSCLC

The oral molecular glue degrader aims to overcome resistance to standard ALK tyrosine kinase inhibitor therapies.

TRIANA Biomedicines’ TRI-611 Granted U.S. FDA Fast Track Designation for Treatment of ALK Positive Non-small Cell Lung Cancer

TRIANA Biomedicines, Inc. (TRIANA), a leading biopharmaceutical company focused on advancing a target-first and proximity-first molecular glue discovery platform to address difficult to drug disease ...
Healio

FDA grants fast track designation to nipocalimab for adults with lupus

The FDA has granted fast track designation to the anti-FcRn agent nipocalimab for the treatment of adults with systemic lupus ...

Quoin Pharmaceuticals Announces FDA Grants Fast Track Designation for QRX003 for the Treatment of Netherton Syndrome

Fast Track Designation facilitates development and expedites regulatory review of therapies addressing serious conditions with significant ...

FDA provides fast track designation to nipocalimab for systemic lupus erythematosus

Johnson & Johnson's nipocalimab has been granted U.S. Food and Drug Administration Fast Track designation as a potential ...

Remix Therapeutics Granted FDA Fast Track Designation for REM-422 for the Treatment of Recurrent, Metastatic or Unresectable Adenoid Cystic Carcinoma

Preliminary Phase 1 Study Results Show Strong Anti-Tumor Activity and Favorable Safety Profile for First-in-Class Small Molecule MYB mRNA ...
Seeking Alpha

FDA Grants Fast Track Designation to NS-229 for the Treatment of Eosinophilic Granulomatosis with Polyangiitis

PARAMUS, NJ., Sept. 9, 2025 /PRNewswire/ -- NS Pharma, Inc. (NS Pharma) a subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku), announced today that the U.S Food & Drug Administration (FDA) has ...
Nasdaq

Allarity Therapeutics Granted FDA Fast Track Designation for Stenoparib for the Treatment of Advanced Ovarian Cancer

TARPON SPRINGS, Fla., August 26, 2025-- Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a ...
Cure Today

FDA Grants Fast Track Designation to ADCE-D01 for Soft Tissue Sarcoma

ADCE-D01 targets the uPARAP protein in sarcomas, delivering medication directly to cancer cells, showing promise in early studies. The ADCElerate1 trial evaluates ADCE-D01's safety, tolerability, ...
Cure Today

MNV-201 Secures FDA Fast Track Designation in Myelodysplastic Syndrome

MNV-201, a mitochondrial cell therapy, received FDA fast track designation for myelodysplastic syndrome, highlighting its potential to address mitochondrial dysfunction in this serious blood disorder.
Healio

FDA grants fast track designation to vectorized antibody to treat ALS

Please provide your email address to receive an email when new articles are posted on . VTx-002 targets proteins that play a significant role in neurodegenerative disease. Enrollment in and ...
Business Wire

Affinia Therapeutics Granted FDA Fast Track Designation for AFTX-201 as a Treatment for People Living with BAG3-Associated Dilated Cardiomyopathy (DCM)

WALTHAM, Mass.--(BUSINESS WIRE)--Affinia Therapeutics (“Affinia”), an innovative gene therapy company with a pipeline of first-in-class and/or best-in-class adeno-associated virus (AAV) gene therapies ...