The FDA's Peripheral and Central Nervous System Drugs Advisory Committee agreed to hold a second hearing reconsidering the company’s NDA for AMX0035 after the agency determined that additional analyses of data submitted by the Company from its clinical studies constituted a major amendment to the NDA. The rehearing is a rare one for an advisory committee, which in March recommended 6-4 against agency approval of the ALS combination drug. The FDA usually follows the recommendations of its advisory committees but does not have to . . .

Get GEN Edge Today!

See More on the Edge

Continue reading this article and more
with a GEN Edge subscription

Start Your 30-Day Free Trial Now

Log In Join GEN Edge