More Action, Less Plan? House Keeps Pressure On US FDA Over ALS Drugs
A bipartisan letter from several key legislators is pushing the US FDA to match its actions to its rhetoric when it comes to the handling of ALS drug reviews. Amylyx’ pending AMX0035 isn’t mentioned but seems unavoidably the subject.
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Tolerating False Positives: Amylyx, FDA, And The Legal Case For Broad Regulatory Flexibility
Amidst bipartisan congressional pressure to approve ALS drugs, Billy Dunn, head of FDA’s neuroscience division, told advisory committee members that the law ‘demands’ flexibility in review of Amylyx’s AMX0035, and he came prepared with the citations.
A Pivotal September For US FDA And Commissioner Califf
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