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 ...
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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.
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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 ...

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 ...

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 ...
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Werewolf Therapeutics Receives Fast Track Designation from the U.S. FDA for WTX-124, an Investigational Therapy for the Treatment of Cancer

WATERTOWN, Mass., Oct. 08, 2025 (GLOBE NEWSWIRE) -- Werewolf Therapeutics, Inc. (HOWL), pioneering the development of therapeutics engineered to stimulate the body’s immune system for the treatment of ...
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Nektar Therapeutics Receives Fast Track Designation for Rezpegaldesleukin for the Treatment of Severe-to-Very Severe Alopecia Areata

SAN FRANCISCO, July 29, 2025 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ...
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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 ...
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Avenzo Therapeutics Granted Fast Track Designation for AVZO-103, a Potential Best-in-Class Nectin4/TROP2 Bispecific Antibody-Drug Conjugate, for the Treatment of Patients with ...

SAN DIEGO--(BUSINESS WIRE)--Avenzo Therapeutics, Inc. (“Avenzo”), a clinical-stage biotechnology company developing next-generation oncology therapies, today announced the U.S. Food and Drug ...