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 ...

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 ...

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 ...
PharmiWeb

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 ...
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 ...

Argo Biopharma Receives FDA Fast Track Designation for BW-20805, an Investigational siRNA Therapy for the Treatment of HAE

Argo Biopharmaceutical Co., Ltd. (Argo Biopharma), a clinical-stage small interfering RNA (siRNA) therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has granted ...

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

AFTX-201 is designed using Affinia's proprietary capsid engineered for efficient cardiac transduction at doses that are 5-10-fold lower than doses of gene therapies using conventional capsids WALTHAM, ...
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.
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, ...
Seeking Alpha

Incannex Granted FDA Fast Track Designation for IHL-42X in Obstructive Sleep Apnea (OSA)

MELBOURNE, Australia and NEW YORK, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (IXHL), a clinical-stage biopharmaceutical company developing innovative combination therapies, announces ...
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 ...