Biogen, Eisai say injectable Alzheimer’s therapy granted FDA review
Biogen (BIIB) and Eisai's (ESALF) (ESAIY) announce that U.S. FDA agreed to review their subcutaneous form of Alzheimer's ...
Johnson & Johnson Gets FDA Fast-Track Designation for Posdinemab in Alzheimer's
The New Brunswick, N.J., pharmaceutical giant said posdinemab has shown potential in targeting disease-associated phosphorylated tau in cerebrospinal fluid from treated Alzheimer's patients, and in ...
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Zunveyl: An Improved Alzheimer's Drug With Fewer Side Effects Will Be Available Soon
Fact checked by Nick Blackmer Zunveyl (benzgalantamine)—a better-tolerated version of the Alzheimer’s drug Razadyne ...
Benzinga.com1d
FDA To Review Under the Skin Weekly Autoinjector For Biogen/Eisai's Alzheimer's Drug Leqembi
FDA sets August ... in 15 seconds. Get Real-Time News and Alerts for Your Portfolio Leqembi is indicated for Alzheimer’s ...
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Inspector General Questions FDA’s Accelerated Approval for Biogen, Sarepta Drugs
An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, ...
Business Insider2d
FDA Accepts Eisai And Biogen's BLA For Subcutaneous LEQEMBI For Early Alzheimer's Disease
or mild dementia stage of disease. A Prescription Drug User Fee Act (PDUFA) action date is set for August 31, 2025. If LEQEMBI subcutaneous maintenance dosing is approved by the FDA, LEQEMBI will ...
Business Insider9d
FDA Accepts Final Protocol for Pivotal Phase 3 Alzheimer’s Disease Study, Streamlining Development Pathway
("Annovis" or the "Company"), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer’s disease (AD) and Parkinson’s ...
Yahoo Finance6d
Alzheimer’s Drugs Eyed as Next Big Obesity-Like Opportunity
(Bloomberg) -- Investors seeking the next obesity-like market opportunity will be closely watching developments related to treatments for Alzheimer’s ... get a strong disease-modifying drug ...
Morningstar8d
Johnson & Johnson Gets FDA Fast-Track Designation for Posdinemab in Alzheimer's
Johnson & Johnson on Wednesday said it has won Food and Drug Administration fast-track designation for its proposed posdinemab treatment for Alzheimer's disease ... The FDA's fast-track program ...
The Boston Globe5d
Alzheimer’s drugs eyed as next big obesity-like opportunity
Firms developing Alzheimer’s drugs have ... received FDA clearance in July 2024, and investors will get more of an indication in the coming year about how adoption of the drug will fare against ...