The U.S. Food and Drug Administration has granted Fast Track Designation to a new drug combination for metastatic colorectal cancer, following encouraging results from a clinical trial led in part by ...

SAT-3247 has now received FDA Fast Track, Orphan Drug and Rare Pediatric Disease designations for Duchenne muscular dystrophy (“Duchenne” or ...

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 ...

Registrational Phase 3 Trial Expected to Begin as Early as Q4 2026Detailed Phase 1b Data Expected to be Presented at a Major Medical Conference ...

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 ...

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 ...

HENDERSON, Nev.--(BUSINESS WIRE)--Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that the U.S. Food and Drug ...

Halia Therapeutics, Inc., a clinical-stage biopharmaceutical company developing first-in-class therapies targeting inflammasome-driven disease biology, today announced that the U.S. Food and Drug ...

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 ...

FDA cleared the Harmony-HHT Phase 1/2 study design, enabling Atavistik Bio to leverage existing clinical data with ATV-1601 ...