Updated: After long and winding road, FDA approves Amylyx's ALS drug in victory for patients and advocacy groups

Max Gelman

Senior Editor

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

BECOME A PREMIUM SUBSCRIBER

Updated: After long and winding road, FDA approves Amylyx's ALS drug in victory for patients and advocacy groups

Max Gelman

Senior Editor

Unlock this article instantly by becoming a free subscriber.

Cash, chips and talent: Inside Nvidia's plan to dominate biotech's AI revolution

A majority of pharma and biotech companies prohibit ChatGPT use, survey finds

GSK unveils long-term Shingrix data as shingles competition heats up

Senate bill targeting WuXi won't affect federal spending, CBO says

Vertex, Alpine’s IgAN drug has Humira-like potential. But not all indications are created equal

Rare neuro disorder offers new area for competition, analysts say: #AAN24

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

Max Gelman

Senior Editor

Unlock this article instantly by becoming a free subscriber.

more like this

Cash, chips and tal­ent: In­side Nvidi­a's plan to dom­i­nate biotech's AI rev­o­lu­tion

A ma­jor­i­ty of phar­ma and biotech com­pa­nies pro­hib­it Chat­G­PT use, sur­vey finds

GSK un­veils long-term Shin­grix da­ta as shin­gles com­pe­ti­tion heats up

Sen­ate bill tar­get­ing WuXi won't af­fect fed­er­al spend­ing, CBO says

Ver­tex, Alpine’s IgAN drug has Hu­mi­ra-like po­ten­tial. But not all in­di­ca­tions are cre­at­ed equal

Rare neu­ro dis­or­der of­fers new area for com­pe­ti­tion, an­a­lysts say: #AAN24

Updated: After long and winding road, FDA approves Amylyx's ALS drug in victory for patients and advocacy groups

Cash, chips and talent: Inside Nvidia's plan to dominate biotech's AI revolution

A majority of pharma and biotech companies prohibit ChatGPT use, survey finds

GSK unveils long-term Shingrix data as shingles competition heats up

Senate bill targeting WuXi won't affect federal spending, CBO says

Vertex, Alpine’s IgAN drug has Humira-like potential. But not all indications are created equal

Rare neuro disorder offers new area for competition, analysts say: #AAN24