Enlarge / The Food and Drug Administration headquarters in White Oak, Maryland. (credit: Getty | Congressional Quarterly ) Less than five weeks after granting a highly controversial approval for the Alzheimer’s drug Aduhelm, the Food and Drug Administration has updated its recommendation for who should receive the drug. The update narrows the recommended patient pool […]
Enlarge / Pedestrians walk past Biogen Inc. headquarters in Cambridge, Massachusetts, on Monday, June 7, 2021. Biogen Inc. shares soared after its controversial Alzheimer’s disease therapy was approved by US regulators. (credit: Getty | Bloomberg) Concern is mounting over the price of the controversial new Alzheimer’s drug Aduhelm. Advocates, lawmakers, and critics worry in particular […]
Enlarge / The Food and Drug Administration headquarters in White Oak, Maryland. (credit: Getty | Congressional Quarterly) A leading advocacy and watchdog group is calling for the ouster of three top officials at the Food and Drug Administration—including its acting commissioner—after the regulator issued a highly contentious approval last week of the unproven and now […]
Enlarge / The Food and Drug Administration headquarters in White Oak, Maryland. (credit: Getty | Congressional Quarterly) Fallout continues from the Food and Drug Administration’s contentious decision this week to approve Biogen’s Alzheimer’s drug Aduhelm (aducanumab) despite a lack of efficacy data. Three experts who sat on an advisory committee for the FDA have now […]
Enlarge (credit: Getty | Congressional Quarterly) The US Food and Drug Administration on Monday approved the antibody drug Aduhelm (generic name aducanumab) to treat Alzheimer’s disease. Aduhelm is the first new Alzheimer’s drug to earn FDA approval since 2003. It’s also the first drug to target a theoretical cause of the irreversible neurodegenerative disease—clumps of […]
Our mission to make business better is fueled by readers like you. To enjoy unlimited access to our journalism, subscribe today. The U.K. government has approved AstraZeneca’s COVID-19 vaccine for emergency use, becoming the first government to do so. The decision by the U.K. drugs regulator will clear the way for tens of millions of Britons […]