FDA actions in brief

An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines Agency (EMA) considerate it as an alternative than the current lower FDA-approved dosage.

Regulatory officials have identified 82 cases worldwide from the FDA Adverse Event Reporting System of anaphylaxis associated with the use of Coxapone and the generic Glatopa that have resulted in hospitalization or death.

The investigational advanced melanoma combination therapy consisting of RP1 and nivolumab have a PDUFA action date of July 22, 2025.

Trump has reversed some of President Biden’s initiatives, including $2 monthly out-of-pocket cap on some generics and experimental pricing models for gene therapies. But so far the healthcare elements of the Inflation Reduction Act remain unchanged.

Datroway reduced disease progression by 37% when compared with chemotherapy.

CEO Andrew Witty promised that UnitedHealthcare would work to speed up turnaround times for approval of some procedures and services in Medicare Advantage plans.