Alzheimer's, FDA
FDA panel to debate US approval for Alzheimer's drug from Eisai and Biogen
A panel of experts on Friday will discuss whether to recommend traditional U.S. regulatory approval for Eisai and Biogen's new Alzheimer's drug Leqembi, a move expected to expand Medicare payment for the treatment.
Alzheimer’s Drug Market To Hit $13B As FDA Approvals And Insurance Coverage Escalate
Alzheimer's disease drug Leqembi will be covered by Medicare once the Food and Drug Administration grants traditional approval, which could come as soon as early July.
Eisai and Biogen’s Alzheimer’s Drug Moves Closer to Full US Approval
Eisai Co. and Biogen Inc. moved closer to full US approval for their Alzheimer’s drug Leqembi after the Food and Drug Administration posted documents indicating it sees no barriers to clearance, setting the product up for likely government health-plan coverage.
FDA advisers to discuss full approval of Alzheimer's drug
Expert advisers to the Food and Drug Administration are slated to guide the agency’s decision on whether to grant full approval to the first Alzheimer’s drug in a new class of treatments. Those who track the FDA closely aren’t expecting fireworks to fly during today’s advisory committee meeting,
Biogen Stock Halted as FDA Committee Considers Alzheimer’s Drug
Trading in shares of Biogen remains halted Friday morning as a Food and Drug Administration advisory committee meets to discuss whether the Alzheimer's drug Leqembi from the company and partner Eisai merits full approval.
FDA advisors to weigh whether Alzheimer's drug Leqembi should receive full approval
Medicare has promised to broadly cover Leqembi, which costs $26,500 per year, if the FDA grants full approval of the treatment.
Biogen Takes Alzheimer’s Drug to FDA Advisers. The Last Time Was a Disaster.
The agency's Peripheral and Central Nervous System Drugs Advisory Committee will consider whether a Phase 3 study confirms the drug's clinical benefit.
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Food and Drug Administration (FDA) and Clarivate Extend Material Transfer Agreement for Three Additional Years
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