FDA actions in brief

Augtyro, approved last month, launched with a month wholesale acquisition $29,000 for patients with ROS1-positive non-small cell lung cancer.

Fabhalta was approved to treat patients with paroxysmal nocturnal hemoglobinuria and will have a wholesale acquisition cost of $550,000 per year.

Jaypirca is also approved to treat mantle cell lymphoma. It has a list price of $21,000 for a 30-day supply.

Twice-daily danuglipron was being studied in a phase 2 study in adults with obesity. Pfizer is now conducting a pharmacokinetic study for a once-daily formulation.

The FDA has set a date of July 07, 2024, for Zorvye 0.15% for adults and children six and up with the chronic skin disease atopic dermatitis.