Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012 The Breakthrough Designation is granted to […]readmore
Tags : Axsome
Shots: The US FDA has granted the BTD for AXS-05 to treat AD agitation. The designation offers potential for expedited development and review The designation was based on P-II/III ADVANCE-1 […]readmore
1. Arena’s APD418 Receives FDA’s Fast Track Designation to Treat Patients with Decompensated Heart Failure Published: Jan 17, 2020 | Tags: Arena, APD418, Receives, FDA, Fast Track Designation, Treat, Patients, Decompensated […]readmore
Shots: Pfizer to receive Axsome’s common shares of ~$8M, $3M in cash as upfront, ~$323M regulatory & commercial milestones and royalties in sales of the therapies and has right of […]readmore