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The FDA has approved a label change for the obesity drug Wegovy, allowing it to be used to reduce the risk of stroke, heart attacks, and other serious cardiovascular problems in overweight or obese patients. Based on a study showing its effectiveness in cutting heart-related risks, Wegovy is the first medication to receive approval for this purpose, signaling a significant advancement in public health and potentially changing how heart patients are treated.
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Amylyx Pharmaceuticals announced that its ALS drug, Relyvrio, did not show significant benefit in a large phase 3 clinical trial and may be withdrawn from the market. Despite gaining FDA approval in September 2022 based on a small phase 2 trial, the drug failed to outperform a placebo in improving participants' ALS functional scale and overall survival. Now, discussions are underway about potentially withdrawing Relyvrio from the market, raising concerns about the drug's effectiveness and its high cost of about $158,000 per year.
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Federal regulators have delayed a decision on Eli Lilly's potential Alzheimer's treatment, donanemab, and have requested an advisory committee to examine the drug's safety and effectiveness. Eli Lilly expected the FDA to decide on donanemab's approval by the end of the month, but the agency's request for additional information has postponed the decision. Donanemab, if approved, would be the second drug convincingly shown to delay cognitive decline in Alzheimer's patients, targeting amyloid plaque buildup in the brain, but it comes with serious side effects such as brain swelling and bleeding, similar to other plaque-targeting drugs.
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Tissue samples from the brain of Robert Card, who killed 18 people in a shooting rampage in Maine, showed evidence of traumatic brain injury but not chronic traumatic encephalopathy (CTE), according to the Concussion Legacy Foundation. Card, a US Army reservist, had been exposed to low-level blasts during his time at an Army hand grenade training range, potentially contributing to his brain injury.
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Florida's Medicaid call center faces significant challenges, with 8 in 10 calls being automatically disconnected, hindering access to health care. Long wait times and disconnection rates are preventing qualifying families from renewing or accessing Medicaid coverage, contributing to a drop in enrollment by 17% since April.
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