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Articles for Aduhelm, search results for process

US: FDA approves anti-Alzheimer's drug
1 year, 11 months ago

US: FDA approves anti-Alzheimer's drug

Hindustan Times  

The US Food and Drug Administration on Friday approved a new drug designed to slow cognitive decline in those suffering from Alzheimer's disease. It follows the approval of the anti-Alzheimer's drug Aduhelm, which a US congressional investigation criticized for alleged "irregularities." The FDA said in a statement that Leqembi and Aduhelm represent "an important advancement in the ongoing fight to …

Disease Drug Biogen Leqembi Fda Approved
Probe: Alzheimer’s drug approval ‘rife with irregularities’
1 year, 11 months ago

Probe: Alzheimer’s drug approval ‘rife with irregularities’

Associated Press  

WASHINGTON — The Food and Drug Administration’s contentious approval of a questionable Alzheimer’s drug took another hit Thursday as congressional investigators called the process “rife with irregularities.” The 18-month investigation by two House committees detailed “atypical collaboration” between FDA regulators and a company it’s supposed to oversee -- Aduhelm manufacturer Biogen. Thursday’s report urged the agency to “take swift action” …

Drug Fda Biogen Aduhelm
Alzheimer’s drug approval by FDA ‘rife with irregularities,’ probe finds
1 year, 11 months ago

Alzheimer’s drug approval by FDA ‘rife with irregularities,’ probe finds

LA Times  

The FDA’s contentious approval of the questionable Alzheimer’s drug Aduhelm took another hit, as congressional investigators called the process “rife with irregularities.” The Food and Drug Administration’s contentious approval of a questionable Alzheimer’s drug took another hit Thursday as congressional investigators called the process “rife with irregularities.” The 18-month investigation by two House committees detailed “atypical collaboration” between FDA regulators …

Approval Fda Biogen Drug Aduhelm
Column: How the FDA’s lousy judgment and a greedy drug company combined to hit Medicare members hard
3 years, 1 month ago

Column: How the FDA’s lousy judgment and a greedy drug company combined to hit Medicare members hard

LA Times  

The fallout from the Food and Drug Administration’s hasty approval of a new Alzheimer’s drug in June was predicted to be severe: Excessive pricing for a drug lacking strong evidence of effectiveness would impose heavy costs on the healthcare system nationwide, especially on Medicare. The coverage determination process is still underway, but Medicare officials said they’re duty-bound to “plan for …

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Why The FDA's Approval Of A New Alzheimer's Drug Should Worry You
3 years, 6 months ago

Why The FDA's Approval Of A New Alzheimer's Drug Should Worry You

Huff Post  

LOADING ERROR LOADING You might expect Mariah Robertson to applaud last week’s approval of a new drug for Alzheimer’s disease. In the meantime, the Aduhelm decision could set a precedent for how the FDA approaches other treatments ― an “enormously risky move,” as STAT writer Matthew Herper put it, “that could accelerate the public’s access to medicines but upend the …

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