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Amylyx's Relyvrio: The Road To Regulatory Flexibility And US FDA Approval

 
• By Sue Sutter

A Pink Sheet timeline shows the regulatory highs and lows of AMX0035's path to US approval for treatment of amyotrophic lateral sclerosis.

AMX0035 timeline
• Source: Shutterstock

Amylyx Pharmaceuticals, Inc. has experienced a host of US regulatory ups and downs with its amyotrophic lateral sclerosis drug Relyvrio (sodium phenylbutyrate/taurursodiol, also known as AMX0035).

Disappointments included denials of fast-track and breakthrough therapy designation, along with the US Food and Drug Administration review division’s initial advice that a second randomized,

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Potency Assay Issues Delayed US FDA Approval Of Mesoblast’s Ryoncil For Years

 
• By Sue Sutter

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Mesoblast’s Ryoncil: US FDA Changed Its Mind On Need For A Randomized Trial

 
• By Sue Sutter

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Recent and Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

US FDA Advisory Committee Misperceptions Abound … At HHS

 
• By Michael McCaughan

HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.

US FDA Layoffs Hit Conflict-Of-Interest Screening For ODAC Meeting

 
• By Sue Sutter and Derrick Gingery

Screening for conflicts and finding the right expertise for a two-day Oncologic Drugs Advisory Committee meeting on four products has been complicated by the Trump Administration’s initial communications freeze and subsequent layoffs in CDER.