TEEN4 Pharmaceuticals GmbH today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to invobenitug (formerly known as procizumab), for the treatment of ...

SOTIO Biotech , a clinical-stage biopharmaceutical company owned by PPF Group, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track D esignation (FTD) to SOT109 , ...

SAT-3247 has now received FDA Fast Track, Orphan Drug and Rare Pediatric Disease designations for Duchenne muscular dystrophy (“Duchenne” or “DMD”) Fast Track is designed to expedite the ...

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 ...

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.

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 ...

Add Yahoo as a preferred source to see more of our stories on Google. The therapy is being evaluated in the ongoing Phase I/II UPBEAT clinical trial in BAG3 DCM patients. Credit: NMK-Studio / ...

FDA fast track designation targets advanced HCC with FGF19 overexpression after ICI and mTKI exposure, reflecting an unmet-need population with limited post-progression systemic options. Phase 1 ...