The amended dosing regimen was approved based on results from a post hoc analysis of the phase 2 MagnetisMM-3 trial.

The FDA has updated the labeling for Kisunla™ (donanemab-azbt) to include a new recommended titration dosing schedule for adults with early symptomatic Alzheimer disease.

The Food and Drug Administration (FDA) has accepted for review Milestone’s response to issues raised in a Complete Response Letter (CRL) for etripamil nasal spray (Cardamyst ™ ), an investigational ...