Accelerated Approval: ALS Drug Could Test New Congressional Directive On Survival

 
• By Sarah Karlin-Smith

Clene leadership spoke with the Pink Sheet about its push for accelerated approval for its ALS nanoparticle treatment. A new nudge from Congress asking the US FDA to consider survival data in accelerated approval could help.

close up of car speedometer at 160 km/h
House appropriators recently directed FDA to consider survivability data for accelerated approvals. • Source: Shutterstock

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