FDA Staff Indicates Willingness to Approve Biogen's Investigational ALS Drug Despite Safety Concerns.
TL;DR Summary
The FDA has signaled its willingness to approve Biogen's ALS drug tofersen despite a failed pivotal trial, citing the need for flexibility in treating the devastating disease. The agency has previously expressed regulatory flexibility when approving an ALS drug from Amylyx Pharmaceuticals last September, indicating its openness to approving new treatments for the disease.
- FDA indicates willingness to approve Biogen ALS drug despite failed PhIII study Endpoints News
- FDA staff says Biogen's ALS drug may have a 'clinical benefit' on a rare form of the disease CNBC
- Investigational ALS Drug May Have Clinical Benefit, FDA Staff Says Medpage Today
- FDA Releases Briefing Docs for Upcoming Biogen/Ionis Tofersen Adcomm BioSpace
- FDA staff says safety issues with Biogen's ALS drug to not prevent approval Reuters.com
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