amyotrophic lateral sclerosis

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Biogen gets FDA approval for ALS drug Qalsody

After much deliberation, the FDA has granted accelerated approval for Biogen’s tofersen for an ultra-rare form of the neurodegenerative disease amyotrophic lateral scleros

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Phase 3 fail prompts Cytokinetics to abandon ALS drug

There’s been a big disappointment for people with amyotrophic lateral sclerosis (ALS), after Cytokinetics said it was halting a trial of its resedemtiv candidate following

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Speech analysis tech for ALS gets FDA breakthrough tag

Software that can be used to monitor patients with neurodegenerative disorder amyotrophic lateral sclerosis (ALS) using their voice patterns has been granted breakthrough

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FDA advisors split on Biogen’s ALS therapy

But unanimous vote on biomarker validity could support accelerated approval of tofersen.

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ALS drug tofersen will face FDA advisors, says Biogen

Biogen will have to make the case for its amyotrophic lateral sclerosis (ALS) therapy tofersen to an FDA advisory committee in March before it gets a decision on approval.

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