Go or no go? Mirati heads to the FDA
TG Therapeutics and Gilead also await a verdict, and Cytokinetics is set for a panel.
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.
Go or no go? Bristol's first-in-class hopes
April should mark the approval of some of the biggest drugs of 2022, including Alnylam's vutrisiran, while TG will hope to be spared pain at the PI3K adcom.
Go or no go? Bristol’s Lag3 debut
March Pdufa dates are set for relatlimab as well as Akebia’s vadadustat, while Amylyx’s ALS drug heads for a panel.