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Alzheimer’s drug Leqembi backed by FDA advisers for full approval
Controversies surrounding the drug — involving safety concerns, the drug’s modest efficacy and its high cost — continue to swirl.
Medicare outlines plan to expand coverage for costly new Alzheimer’s drugs
The first drug potentially covered by the expanded plan, Leqembi, could be granted full approval from the Food and Drug Administration as soon as this summer.
FDA advisers endorse making birth control pill available over the counter
The vote by the agency’s outside experts increased the likelihood that a contraceptive called Opill will be approved for sale without a prescription.
Birth control pills aren’t available over the counter in U.S. That could change.
For the first time, the Food and Drug Administration is weighing whether to allow a daily contraceptive to be sold over the counter.
Lilly to seek FDA approval for Alzheimer’s drug that firm says slows decline
The drug, donanemab, is the latest treatment to target amyloid beta, a protein that builds up in the brain and is a signature characteristic of Alzheimer’s.
The new face of Alzheimer’s: Early stage patients who refuse to surrender
For years, doctors and patients thought there was little to do when dementia was diagnosed, even at an early stage. Now, potentially sweeping changes loom.
White House plans to nominate cancer center chief to lead NIH
The National Institutes of Health has not had a permanent director since December 2021, when its longtime leader stepped down.
FDA backs second omicron booster for high-risk groups
The shots would be available for people who are at least 65 years old or immune-compromised.
FDA yanks approval of Makena, only drug cleared to lower preterm birth
The FDA concluded there is no evidence that the drug, which had been cleared by the agency through accelerated approval in 2011, works.
FDA to okay second omicron-targeting booster for some, officials say
The Biden administration is moving to make the shot available for older people and those with impaired immune systems.
