Moderna Unveils Promising mRNA-4359 Cancer Antigen Therapy Data in Melanoma Ahead of ESMO 2025

Moderna; mRNA-4359; cancer antigen therapy; melanoma; ESMO 2025; checkpoint inhibitor-resistant; PD-L1; IDO1; objective response rate; disease control rate; immunotherapy; Phase 1/2 trial; pembrolizumab

FDA Delays Denali’s Hunter Syndrome Therapy Decision by Three Months

FDA delay; Denali Therapeutics; Hunter syndrome; tividenofusp alfa; MPS II; Biologics License Application (BLA); review extension; clinical pharmacology; major amendment; accelerated approval