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FDA Skeptical of Benefits From Experimental ALS Drug

The Food and Drug Administration has issued a negative review of a closely watched experimental drug for the debilitating illness known as Lou Gehrig’s. ....

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Pressured by patients, FDA reviews ALS drug with modest data

When patients are battling a terminal illness and want access to an experimental drug, how much evidence that it works should regulators require before approval? That’s the question behind many of the Food and Drug Administration’s toughest decisions, including last year's controversial approval of Aduhelm. Many experts — including the… ....

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FDA reviews ALS drug after push

When patients are battling a terminal illness and want access to an experimental drug, how much evidence that it works should regulators require before approval? ....

United Kingdom , United States , Lou Gehrig , Joseph Ross , Jeffrey Rothstein , Catherine Lomen Hoerth , Larry Falivena , Johns Hopkins University , Yale University , Drug Administration , University Of California San Francisco , Amylyx Pharmaceutical , Johns Hopkins , California San Francisco , New England Journal ,

Pressured by patients, FDA reviews ALS drug with modest data

The Food and Drug Administration meets next week to review a closely watched drug for ALS, following months of lobbying by patient groups and lawmakers. ....

United Kingdom , United States , Sandra Abrevaya , Brian Wallach , Jeffrey Rothstein , Lou Gehrig , Joseph Ross , Johns Hopkins , Patrizia Cavazzoni , Catherine Lomen Hoerth , Larry Falivena , Johns Hopkins University , Yale University , Drug Administration , Amylyx Pharmaceutical , New England Journal ,

Pressured by patients, FDA reviews ALS drug with modest data - New Delhi Times - India Only International Newspaper

When patients are battling a terminal illness and want access to an experimental drug, how much evidence that it works should regulators require before approval? That’s the question behind many of the Food and Drug Administration’s toughest decisions, including last year’s controversial approval of Aduhelm. Many experts including the agency’s own outside advisers … ....

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