Aduhelm Label Update Includes Seizure Risk And Recommends More MRIs
New safety information may help defense of CMS's coverage restrictions. FDA updated the prescribing information for Biogen’s Alzheimer's therapy after four cases of seizures were reported in a trial.
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Keeping Track: AZ’s Busy Oncology Biz, Phathom’s Voquezna Approval, And A Trio Of Complete Response Letters
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Recent congressional reactions to the Medicare national coverage determination offers insight into policies around CMS decision-making that could advance if Republicans gain more control in Congress in 2023.
Final Medicare national coverage determination aims to set up a ‘nimble’ system to allow for broad and rapid patient access to drugs for Alzheimer’s disease following traditional approval while retaining a more restrictive approach for accelerated approvals.