Go or no go? The FDA’s Amylyx dilemma

A year after misjudging Aduhelm the FDA has another tough decision to make: whether to approve Amylyx’s amyotrophic lateral sclerosis treatment AMX0035. While the robustness of the clinical data has come under fire, pressure from patient groups and physicians could sway the regulator.

The FDA will also be busy with panel meetings next month, with established Covid vaccine makers hoping to extend the jabs' reach into younger age groups, and Novavax finally getting in front the agency.