FDA Actions in Brief

Markary, a surgeon at Johns Hopkins, gave safe, vague and polished answers to senators' questions on mifepristone and the cancellation of an FDA vaccine committee meeting.

Neffy 1 mg is now approved by the FDA to treat pediatric patients who weigh 33 to 65 lbs. Neffy was first FDA-approved as a 2 mg dose in August 2024 for the emergency treatment of anaphylaxis in children and adults weighing at least 66 lbs.

NovoCare Pharmacy will provide all dose strengths of Wegovy at a reduced cost of $499 per month for cash-paying patients without insurance.

The FDA has accepted Amneal’s biologics licensing application for two biosimilars referencing Prolia and Xgeva.

The FDA had approved Otulfi in September 2024 to treat Crohn’s disease, ulcerative colitis, psoriasis and active psoriatic arthritis. Information on pricing is not yet available.