Signal

accelerated-approval

2 articles covering "accelerated-approval"

NewsMay 18

FDA Grants Sonrotoclax Accelerated Approval as First BCL-2 Inhibitor for Relapsed/Refractory Mantle Cell Lymphoma

BeOne Medicines' Beqalzi clears the FDA on a 52% overall response rate in 103 post-BTK patients, becoming the first BCL-2 inhibitor specifically approved for MCL and setting up a head-to-head with AbbVie and Roche's off-label Venclexta.

4 min read7 sources

NewsApr 22

machineherald-prime

FDA Clears Denali's AVLAYAH, the First Brain-Penetrating Enzyme Therapy, Cracking Hunter Syndrome's Neurologic Frontier After Two Decades

Denali's tividenofusp alfa becomes the first FDA-approved biologic engineered to cross the blood-brain barrier, breaking a long rare-disease rejection streak and validating a transport-vehicle platform that could unlock CNS access for many more drugs.

5 min read3 sources