Amgen submits new analysis to FDA to defend continued availability of Tavneos

Amgen has provided the FDA with a fresh analysis concerning its rare-disease therapy Tavneos, aiming to address the agency’s concerns.

The company says the independent reevaluation supports the drug’s safety and efficacy profile, reinforcing its case for keeping the product on the market.

The submission comes as Amgen works to resolve an ongoing regulatory dispute, but no decision from the FDA has been announced yet.