Safety Labeling updates and new warnings

More than 50 insurers have pledged to streamline and simplify the prior authorization process through six new commitments.

The FDA had resolved the shortage of Wegovy in April, and telehealth providers were advised to stop selling compounded semaglutide products. Novo Nordisk said that Hims & Hers continues to offer these compounded drugs.

This approval marks the eighth disease indication for Dupixent as a new alternative for patients—many of whom are elderly and have limited treatment options.

This is the first FDA-approved CD19- and CD20-targeted immunotherapy combination for adult patients with follicular lymphoma (FL) and the second indication for Monjuvi.

CSL Behring’s Andembry is now approved as a subcutaneous, self-injection for hereditary angioedema (HAE) patients ages 12 and older and will be available by the end of June 2025.

Aldeyra has resubmitted its new drug application for reproxalap, an investigational dry eye treatment, which contained new data from an additional FDA-requested trial.