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…
OTOF gene therapy restored hearing after one inner‑ear injection in a 10‑patient trial — who it helps and what comes next
A single inner‑ear injection of AAV‑mediated gene therapy that replaces the defective OTOF gene restored measurable hearing in all ten…
Solriamfetol delivers measurable wakefulness gains for early‑morning shift workers with shift work disorder
Clinical trial data show solriamfetol can modestly but reliably increase wakefulness in people with shift work disorder who start work…
Fabhalta vs placebo: 49.3% slower eGFR decline and 43% fewer kidney‑failure events in IgA nephropathy — a progression‑slowing therapy, not a cure
Novartis’ Phase III APPLAUSE‑IgAN trial published in the New England Journal of Medicine and presented at the 2026 World Congress…
Retatrutide Phase 3 (TRANSCEND‑T2D‑1) cut A1C up to 2.0% and body weight up to 16.8% after 40 weeks
Eli Lilly’s investigational triple agonist retatrutide produced large reductions in both A1C and body weight in TRANSCEND‑T2D‑1, a 537‑person Phase…
Weekly injectable extended‑release buprenorphine increased prenatal opioid abstinence and reduced serious maternal adverse events
An NIH‑supported randomized trial of 140 pregnant adults with opioid use disorder found that weekly injectable extended‑release buprenorphine produced higher…