FDA Fast Track opens new path for Imugene's Azer-cel - ICYMI

Imugene Ltd (ASX:IMU, OTC:IUGNF, FRA:ILA) earlier this week announced that the US Food and Drug Administration (FDA) granted ...
Medical Xpress

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 treatment for adults with systemic lupus erythematosus (SLE). Fast Track ...
Monthly Prescribing Reference

FDA Grants Fast Track Status to BNT113 for HPV16+ Head and Neck Cancer

The FDA's Fast Track designation helps to accelerate the development and review of products for serious and life-threatening conditions. The Food and Drug Administration (FDA) has granted Fast Track ...
Cure Today

FDA Grants Fast Track Status to New Gastric Cancer Treatment

DPTX3186 targets the Wnt/β-catenin pathway, crucial in gastric cancer, by forming drug-induced condensates to modulate β-catenin activity. Fast track designation accelerates development and review, ...
Business Wire

Precision BioSciences Receives U.S. FDA Fast Track Designation for PBGENE-HBV, a First-In-Class Gene Editing Therapy Designed to Eliminate the Root Cause of Chronic Hepatitis B

DURHAM, N.C.--(BUSINESS WIRE)--Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS ® platform to develop in vivo gene editing ...
Cure Today

FDA Gives Fast Track Designation to Stenoparib in Advanced Ovarian Cancer

Stenoparib, targeting PARP1/2 and tankyrase 1/2, offers a unique mechanism for treating advanced ovarian cancer. The FDA's fast track designation facilitates expedited development and review, with ...