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More Action, Less Plan? House Keeps Pressure On US FDA Over ALS Drugs

 
• By Michael McCaughan

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.

Congress and ALS
Congressional leaders are showing their support for ALS products • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock images

Several key members of the House of Representatives are urging the US Food & Drug Administration to back up its public statements about “flexibility” in considering ALS therapies with some concrete actions.

House Energy & Commerce/Health Subcommittee Chair Anna Eshoo (D-CA) organized the bipartisan letter, and ranking member Brett Guthrie (R-KY)...

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