September FDA Actions in brief

If approved, Molbreevi could be the first FDA-approved treatment for patients with autoimmune pulmonary alveolar proteinosis, a rare lung disease.

Tryngolza is once-monthly, subcutaneous RNA-targeted therapy and is expected to be available by the end of the year with a price of $595,000.

The Institute for Clinical and Economic Review assessed the formularies of 11 payers, covering 57 million people, to determine access for drugs that the organization had reviewed in 2022 for cost-effectiveness.

Originally approved in 2009, Stelara patents began expiring in 2023, leading to an influx of recent biosimilars.

The boxed warning follows a safety warning the FDA issued in September about the risk of liver injury from the use of Veozah to treat hot flashes.

A new bill in Congress would require pass-through prices in both Medicare, and Medicaid and require transparency of PBM practices in the commercial space.