FDA grants Fast Track to SOT109, an ADC targeting CDH17 for advanced colorectal cancer
The U.S. Food and Drug Administration has granted Fast Track Designation to SOTIO Biotech’s investigational antibody‑drug conjugate SOT109, which targets…
With FDA Fast Track, Coya’s COYA 302 advances to a make-or-break Phase 2 readout expected in early 2027
Coya Therapeutics’ investigational ALS therapy COYA 302 has been granted FDA Fast Track designation while the randomized, double‑blind ALSTARS Phase…
FDA Fast Track for tazbentetol follows positive Phase 2a signals — next stop: phase 3
The FDA has granted Fast Track designation to tazbentetol, an oral drug from Spinogenix that uses a synaptic-regenerative mechanism to…