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 Degrader No Approved Treatment Options for Patients with ...
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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 erythematosus, according to a manufacturer press release. Nipocalimab ...
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FDA Provides Fast Track Designation to Nipocalimab for Systemic Lupus Erythematosus

Nipocalimab has been granted U.S. Food and Drug Administration Fast Track designation as a potential treatment for adults with systemic lupus erythematosus (SLE). Fast Track designation is designed to ...

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 ...

Polaryx Therapeutics Receives FDA Fast Track Designation for PLX‑200 for Late‑Infantile Neuronal Ceroid Lipofuscinosis (CLN2 Disease)

Regulatory milestone supports advancement of the SOTERIA Phase 2 basket trial evaluating PLX‑200 across multiple lysosomal storage ...

FluoGuide Receives FDA Fast Track Designation for FG001 in High-Grade Glioma

COPENHAGEN, DENMARK / ACCESS Newswire / March 18, 2026 / FluoGuide A/S (STO:FLUO) ("FluoGuide" or the "Company"), a biotech company maximizing surgical outcomes in oncology by lighting up cancer, ...
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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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Novel siRNA Therapy for Hereditary Angioedema Receives Fast Track Status

The FDA awards Fast Track designation to BW-20805 for hereditary angioedema, a therapy designed to reduce attacks through PKK suppression.
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MoonLake Announces FDA Fast Track Designation for Sonelokimab Palmoplantar Pustulosis (PPP) and Provides Details on Upcoming Investor Day

The Dermatology Division of the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to sonelokimab (SLK) in moderate-to-severe palmoplantar pustulosis (PPP) supported by ...
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Johnson & Johnson therapy nipocalimab granted U.S. FDA Fast Track designation in systemic lupus erythematosus (SLE)

Fast Track designation reflects the unmet need in this serious disease and enables the potential for an accelerated FDA review timeline The designation is supported by a Phase 2 study in which ...
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FDA Grants Fast Track Designation to Corbus Pharmaceuticals’ Nectin-4 Targeting ADC CRB-701 in Head and Neck Squamous Cell Carcinoma

Dose optimization data from the Phase 1/2 study to be presented next month at ESMO 2025 Second Fast Track designation granted by FDA for CRB-701 CRB-701 (SYS6002) is a next-generation antibody drug ...
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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 ...