Go or no go? GSK takes its turn with a novel anaemia class
Amicus and Astrazeneca have notable approaching Pdufa decisions, while a panel for GSK’s daprodustat could change the course of a controversial drug class.
Amylyx’s fortunes shift again
FDA approval of the company’s ALS project seems assured, but pledges of withdrawal on phase 3 failure come with caveats.
Brace for an end-of-year boost to drug approvals
The first half of 2022 was slow on the regulatory front, but plenty of big decisions remain for Bristol Myers Squibb, Apellis and others.
US drug pricing reform happens at last
As a host of industry-hated proposals look like becoming law in the US, Evaluate Vantage explains what might be coming.
Is biopharma getting better at accelerated approval conversions?
Amid ongoing pressure to reform the FDA’s fast-track pathway, signs emerge that the criticism is being heard.
