FDA

New ALS drug gets FDA approval despite questionable data

New ALS drug gets FDA approval despite questionable data

WASHINGTON (AP) — A highly controversial drug for Lou Gehrig’s disease won U.S. approval Thursday, a long-sought victory for patients that is likely to renew questions about the scientific rigor behind government reviews of experimental drugs. The Food and Drug Administration approved the drug from Amylyx Pharmaceuticals based on the results of a small, mid-stage …

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FDA approves controversial new drug designed to slow progression of ALS

FDA approves controversial new drug designed to slow progression of ALS

The Food and Drug Administration on Thursday approved a controversial new drug designed to slow the progression of Lou Gehrig’s disease, a victory for patients and advocates despite limited evidence that the drug is effective. The drug, from Amylyx Pharmaceuticals of Massachusetts, joins just a handful of agency-approved drugs for the deadly neurodegenerative disease and …

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ALS Drug Gains FDA Approval Despite Uncertainty About Its Effectiveness |  CNN

ALS Drug Gains FDA Approval Despite Uncertainty About Its Effectiveness | CNN

CNN — A new treatment for amyotrophic lateral sclerosis, or ALS, has been approved by the US Food and Drug Administration. The FDA announced Thursday the approval of Relyvrio, developed by Amylyx Pharmaceuticals. According to the company, the oral drug can be taken as a stand-alone therapy or alongside other treatments, and has been shown …

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The Rotten FDA Definition of "Healthy" Foods Is Finally Thrown Away

The Rotten FDA Definition of “Healthy” Foods Is Finally Thrown Away

The U.S. Food and Drug Administration on Wednesday proposed a long-awaited revision to the definition of “healthy” on food packaging – finally removing mind-boggling 1990s criteria that made foods such as nuts, salmon, avocados, olive oil, and even water not eligible for the label. The new definition is not immune to criticism, and Americans are …

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FDA approves first ALS drug in 5 years after patient appeals

FDA approves first ALS drug in 5 years after patient appeals

On Thursday, the Food and Drug Administration overcame the doubts of agency scientists and approved a hotly debated drug for ALS, a decision that encouraged patients and advocates who lobbied for the drug. drugs, but has raised concerns among some experts about whether treatments for extreme conditions receive sufficient scrutiny. “It’s huge,” said Sunny Brous, …

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Dr Paul Offit, right, warns there are still risks to healthy young people that need to be considered before receiving the COVID booster

FDA vaccine adviser says healthy young people SHOULD NOT get another COVID booster

A top vaccine expert and pediatrician is warning parents of healthy young people not to get the new COVID booster shot, saying it may be risky and has yet to be proven effective. Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the Food and Drug …

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Should I get the flu shot and the COVID-19 shot at the same time?

Should I get the flu shot and the COVID-19 shot at the same time?

As flu season begins, some Marylanders are wondering if they should get the flu shot and the new COVID-19 booster shot at the same time. || COVID-19 Updates | The latest numbers from Maryland | Get Tested | Vaccine Information || The Maryland Hospital Association encourages everyone who is eligible to receive the COVID-19 reminder …

Should I get the flu shot and the COVID-19 shot at the same time? Read More »

Should I get the flu shot and the COVID-19 shot at the same time?

Should I get the flu shot and the COVID-19 shot at the same time?

As flu season begins, some Marylanders are wondering if they should get the flu shot and the new COVID-19 booster shot at the same time. || COVID-19 Updates | The latest numbers from Maryland | Get Tested | Vaccine Information || The Maryland Hospital Association encourages everyone who is eligible to receive the COVID-19 reminder …

Should I get the flu shot and the COVID-19 shot at the same time? Read More »

The FDA looks set to approve a new drug for ALS, but does it work?

The FDA looks set to approve a new drug for ALS, but does it work?

Drugmaker Amylyx is asking the FDA to approve a new drug for ALS, a deadly neurodegenerative disease. It is possible that the agency will give the green light to the drug by the end of the month. Manuel Balce Ceneta/AP hide caption toggle caption Manuel Balce Ceneta/AP Drugmaker Amylyx is asking the FDA to approve …

The FDA looks set to approve a new drug for ALS, but does it work? Read More »