Mvasi™. Amgen Inc.'s Mvasi (bevacizumab-awwb) was approved as a biosimilar to Genentech, Inc.'s Avastin® (bevacizumab). Mvasi treats adults with certain colorectal, lung, brain, kidney, and cervical cancers. This is the first FDA-approved biosimilar to treat cancer.

Aliqopa®. Bayer Healthcare Pharmaceuticals, Inc.'s Aliqopa (copanlisib) was granted accelerated approval to treat adults with relapsed follicular lymphoma who have received at least two prior therapies. Follicular lymphoma is a slow-growing non-Hodgkin lymphoma, a cancer of the lymph system. The FDA previously granted Aliqopa priority review and orphan drug designations.

Reset®. Pear Therapeutics, Inc.'s Reset is the first FDA-authorized mobile medical application to help treat substance use disorders (SUDs). The device is prescribed with outpatient therapy to treat alcohol, cocaine, marijuana, and stimulant SUDs. The FDA authorized the device through the de novo pathway, which allows approval of low-to-moderate risk medical devices that lack a substantially equivalent marketed device without submitting a 510(k) or premarket approval application.