Backed by a phase 3 trial of over 40,000 participants, the investigational trivalent mRNA-1010 vaccine met superiority criteria against a standard-dose comparator with a manageable safety profile.

Transitioning from accelerated to traditional status, the FDA's decision expands eligibility for the first solid-tumor engineered T cell therapy to include adolescents aged 12 and older.

Supported by the phase 3 NIMBLE trial, the novel siRNA met its primary endpoint, demonstrating significant 24-week improvements in MG-ADL scores.