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HHS Xavier Becerra said the 2022 premium should be adjusted downward, but legal and operational hurdles prevented officials from doing that in the middle of the year.
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Aduhelm is the first treatment approved in the country to slow cognitive decline in those living with Alzheimer's. Doctors have refused to prescribe it, given the lack of data and evidence behind it.
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In his resignation letter, Dr. Aaron Kesselheim calls it "probably the worst drug approval decision in recent U.S. history." An FDA official says the agency found the benefits outweighed the risks.
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Aduhelm was recently approved by the FDA and quickly sparked controversy over its price and questionable benefits.
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This is the first new drug approved for Alzheimer's disease since 2003. It's the first to show significant progress against the sticky brain plaques that are the hallmark of Alzheimer's disease.
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The agency is to decide by Monday whether to greenlight Biogen’s drug aducanumab, despite a near-unanimous rejection of the product by an FDA advisory committee of outside experts in November.