pharmaphorum55 分钟
FDA sets August date for subcutaneous Leqembi decision
To date, Leqembi has been approved in the US, Japan, China, South Korea, Hong Kong, Israel, UAE, GB, Mexico, and Macau, and ...
Independence Blue Cross to exclude coverage for some drugs that get accelerated FDA approval
Independence Blue Cross has instituted an 18-month benefit exclusion on certain drugs that receive accelerated approval from ...
AOL20 天
How a new FDA-approved drug can — and can’t — help people with Alzheimer’s
So, what’s really going on? In early 2023, the U.S. Food and Drug Administration (FDA) granted accelerated approval to a new Alzheimer’s drug called Leqembi. (Biogen, a biotechnology company ...
Healthy Returns: The FDA approved fewer new drugs in 2024 — but some big ones hit the market
The FDA wrapped up 2024 with 50 new drug approvals, clearing a wave of long-awaited treatments. Meanwhile, Transcarent will ...
FDA accepts Biologics License Application for subcutaneous maintenance dosing of Leqembi ...
BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announced that the U.S. Food and Drug Administration (FDA) has accepted BioArctic's partner Eisai's Biologics License Application (BLA) for Leqembi ...
pharmaphorum1 天
Lilly gets FDA OK for Alzheimer’s drug, cites cost advantage
which is currently under FDA review. Approval for a monthly IV dose of Leqembi is also being sought. The Alzheimer’s Drug Discovery Foundation (ADDF) also welcomed the approval, saying it would ...
Billed as nonaddictive, new pain pill could soon win FDA approval
A non-opioid painkiller from Vertex Pharmaceuticals could become a blockbuster, but questions remain on whether it will prove ...
Why Alzheimer’s scientists are rethinking the amyloid hypothesis
Recent studies implicate the immune system and a herpes virus as potential contributors to development of disease ...
Novo Nordisk Pushes FDA To Exclude Compounding For Its Early-Generation Diabetes Drug
Danish pharmaceutical giant Novo Nordisk A/S (NYSE:NVO) submitted a Citizen Petition to the FDA requesting the exclusion of ...
Alzheimer’s drugs eyed as next big obesity-like opportunity
Investors seeking the next obesity-like market opportunity will be closely watching developments related to treatments for ...
Alzheimer’s Drug Study Yields Mixed Results. Wall Street Still Likes Axsome.
In one study, the company’s drug eased the agitation for Alzheimer’s patients. In a different study, there wasn’t a ...
FDA Accepts Eisai And Biogen's BLA For Subcutaneous LEQEMBI For Early Alzheimer's Disease
Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) said that the U.S. Food and Drug Administration has accepted Eisai's Biologics ...