FDA approves higher-dose semaglutide under new accelerated review process
The clearance is among the first to run through the agency's newly created expedited review pathway, per AJMC.
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By Daniel Okafor · Regulatory Correspondent
Mar 20 03:00 ETSource: The American Journal of Managed Care
The wire
- 01AJMC reports the FDA approved a higher-dose semaglutide under a new accelerated review process.
- 02A higher approved dose gives prescribers a labeled escalation option and may shift payer step-therapy and compounding demand.
- 03Dose specifics, indication language and coverage decisions will need confirmation from the approved label.
From the source
Read at ajmc.comHigher-Dose Semaglutide Approved Under New FDA Accelerated Review Process