ALS drug gets FDA approval despite uncertainty about effectiveness | CNN

The FDA announced approval of Relyvrio, developed by Amylyx Pharmaceuticals, on Thursday. The oral medication works as a standalone therapy or when added to other treatments, according to the company, and it has been shown to slow disease progression.

In March, the Peripheral and Central Nervous System Drugs Advisory Committee voted 6-4 that a single Phase 2 trial did not establish the conclusion that the drug is effective in treating ALS. “In terms of establishing the conclusion that it’s effective, we were asked to look for substantial evidence with persuasiveness and robustness and I think this one trial doesn’t quite meet that bar,” Dr.

Was just diagnosed with ALS - I do hope it gives me some more time and I hope it will not cost me my house.

Bobulinski ?

StopHazaraGenocide

Following the protests,Iran's dictator regime has attacked Sharif University of Tehran and they are shooting and arresting students They are violating human rights Please be our voice and help us Why is the world quiet?! BBCBreaking nytimes guardian OpIran مهسا_امینی

We need Nurown. That’s the drug that will change ALS. Fyi the ice bucket money, is still sitting in the bank of the als association. 80 million still in the bank. They also took ppp money and gave bonuses to staff.

AMAZING this is the only news from the FDA you are pushing. I would put it on the second page, or at least below the fold on page 1. Amazing your have a news agency infrastructure; but only use it for propaganda. CNN suffers from low T. You can ask the FDA what that is

YES! I am glad to hear this news. Unfortunately for the people I knew with ALS it comes too late but I hope it can help others.

My brother died of ALS at 51 in 2007. It robbed him of so much of his family life as a husband, dad & grandpa. I hope this breakthrough helps others live longer lives.

An excellent start ❤️❤️🙏🙏

Special greetings to whom its may concern I am mr Francisco I work as a special agent against crime and fraudulent acts click the link below and register we arrest and refund whatever victims Lost to them completelyYou can send me a private message to understand about this

alsadvocacy My dad has gone into hospice today … but I hope this drug has hope and life for others. ALS is the worst thing I’ve ever seen. It takes everything and then some. I will miss my dad so much.

It goes to show what we can do when we come together as people.

mahsaamini OpIran

Bill Clinton says ‘there is a limit’ to how many migrants US can take without causing ‘disruption’

Wonderful news!

This is FREAKIN WONDERFUL !!!

Joe Bidens administration doing another win again!

Cool

Sweet 😊

That is so cool! I always wondered what those challenges would accomplish.

United States Latest News, United States Headlines

Similar News:You can also read news stories similar to this one that we have collected from other news sources.

Food and Drug Administration releases new guidelines for ‘healthy’ foodConsumers rely on food labels when navigating grocery stores to make informed choices about the foods they consume.
Source: ksatnews - 🏆 442. / 53 Read more »

Food and Drug Administration issues new guidelines for 'healthy' foodThe requirements vary based on the product type, with a baseline nutrient density for each. FDA nutrients Food restaurant FoodIndustry healthy
Source: SAcurrent - 🏆 607. / 51 Read more »

FDA approves ALS drug whose study was partly funded by Ice Bucket Challenge | CNNThe US FDA has approved a new ALS drug that was backed by patients and advocacy groups. Its study had been partly funded by the viral Ice Bucket Challenge.
Source: cnni - 🏆 326. / 59 Read more »

Biomarker data prove critical for ALS drug evaluation at FDABiomarker data prove critical for ALS drug evaluation at FDA, with a vote recommending approval of AmylyxPharma AMX0035. Our latest column in The Clinical Pipeline, from CyrilPedia
Source: NatureMedicine - 🏆 451. / 53 Read more »

FDA redefines what can be labeled 'healthy': Salmon is in, white bread is notThe Food and Drug Administration is redefining its antiquated criteria for what packaged food can be labeled as 'healthy,' allowing salmon, olive oil, nuts and seeds, and water to qualify. This is basically about which food companies will be allowed to sell to schools and which lobbyists worked for them. Salmon eat poop.
Source: dcexaminer - 🏆 6. / 94 Read more »