Amicus and Astrazeneca have notable approaching Pdufa decisions, while a panel for GSK’s daprodustat could change the course of a controversial drug class.
FDA approval of the company’s ALS project seems assured, but pledges of withdrawal on phase 3 failure come with caveats.
The first half of 2022 was slow on the regulatory front, but plenty of big decisions remain for Bristol Myers Squibb, Apellis and others.
As a host of industry-hated proposals look like becoming law in the US, Evaluate Vantage explains what might be coming.
Amid ongoing pressure to reform the FDA’s fast-track pathway, signs emerge that the criticism is being heard.