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FDA head urges probe of agency’s dealings with Biogen, maker of controversial new Alzheimer’s drug
The approval of Aduhelm set off a firestorm, with critics saying the medication doesn’t work and accusing the agency of getting too close to the company.
FDA, facing intense criticism, narrows use of controversial Alzheimer’s drug to patients with early-stage disease
The revised label clarifies that the drug, called Aduhelm, is intended for patients with early-stage disease — the population that participated in clinical trials of the drug.
The controversial approval of an Alzheimer’s drug reignites the battle over the underlying cause of the disease
The field of Alzheimer’s research has been dominated — and divided — by a hypothesis holding that toxic clumps in the brain are the main driver of the disease and that removing them will slow cognitive decline.
Biden names veteran of last cancer moonshot to help direct new initiative
The announcement signals a ramping up of administration activity on the cancer front.
Juul agrees to pay North Carolina $40 million to settle vaping accusations
North Carolina is the first state to reach a settlement with Juul for allegedly targeting youth through social media advertisements and other outlets. Another 13 states and D.C. also have sued the e-cigarette company.
FDA releases fresh details on internal debate over controversial Alzheimer’s drug
The new information, included in interviews with agency officials and 83 pages of internal documents, might not quiet a furor over the drug Aduhelm that has drawn in Alzheimer’s doctors and patients, members of Congress, Medicare officials, and the age…
Furor rages over FDA approval of controversial Alzheimer’s drug
For days, critics have blasted the approval in opinion columns and tweets, saying there is insufficient evidence of efficacy. Supporters have expressed confidence the drug, Aduhelm, will help patients stay in the earliest stages of the disease longer.
FDA has decided at least 60 million doses of Johnson & Johnson’s coronavirus vaccine must be be discarded; 10 million can be released
The doses underwent a safety review after J&J shots were contaminated with AstraZeneca’s vaccine, prompting a plant shutdown.
Two members of an FDA advisory committee quit after approval of controversial Alzheimer’s drug
The FDA decision to approve Aduhelm set off a firestorm because critics say there is scant evidence the drug is effective.
FDA approves first drug intended to slow cognitive decline caused by Alzheimer’s disease
It is the first drug cleared that is designed to alter the course of the disease by slowing the deterioration of brain function — not just to ease symptoms.
