Amylyx Pharmaceuticals, Inc.
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Latest From Amylyx Pharmaceuticals, Inc.
Top FDA Staff Are Pushing Review Teams To Be Comfortable With Regulatory Flexibility
Senior leadership in the FDA’s drugs, biologics and devices centers want reviewers to feel more comfortable taking risks in product approvals, but may need more concrete examples of regulatory flexibility's success to convince them.
Accelerated Approval: ALS Drug Could Test New Congressional Directive On Survival
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.
Amylyx Steps Outside Neurodegenerative Disease With New Late-Stage Asset
The company outlined plans to develop newly acquired GLP-1 antagonist avexitide. CEOs Joshua Cohen and Justin Klee talked to Scrip about the strategy.
Deal Watch: Lilly Partners With OpenAI On Drug-Resistant Pathogens
Plus transactions involving ANI/Alimera, Gilead/ashibio, Sanofi/Belharra and more.
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