FDA advisors give conditional approval for Biogen's ALS drug, but concerns remain.
TL;DR
A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.
- FDA advisors unanimously recommend accelerated approval for Biogen's ALS drug Endpoints News
- FDA advisors vote against effectiveness of Biogen's ALS drug for rare and aggressive form of the disease CNBC
- Biogen gets mixed decision at FDA AdComm on failed ALS drug as experts back conditional, not full, approval FierceBiotech
- Pharmalittle: FDA panel backs conditional approval for Biogen ALS drug; pharma fights tactic for lowering specialty med costs STAT
- FDA AdComm on Tofersen Supports NfL as Surrogate End Point of Clinical Benefit, But Is It Enough for Approval? Neurology Live
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