Sarepta, Biogen drugs with accelerated approval under fire in FDA report
A report questions the FDA's accelerated approval process citing Sarepta and Biogen therapies as examples. Read more here.
verywellhealth9 小时
Zunveyl: An Improved Alzheimer's Drug With Fewer Side Effects Will Be Available Soon
Zunveyl, an oral medication, is a better-tolerated version of galantamine for managing mild to moderate Alzheimer's symptoms.
Benzinga.com17 小时
FDA To Review Under the Skin Weekly Autoinjector For Biogen/Eisai's Alzheimer's Drug Leqembi
FDA sets August ... subcutaneous dosing allows Alzheimer's patients to administer weekly treatment at home in 15 seconds. Get ...
STAT11 小时
Federal watchdog raises some concerns about the FDA’s accelerated approval program
The Office of the Inspector General reviewed the FDA’s use of accelerated approval for 24 drugs, ultimately finding issues ...
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 ...
Biogen, Sarepta Quick Drug Approvals Show FDA Gaps, Report Says
Approvals for drugs from Biogen Inc. and Sarepta Therapeutics Inc. show flaws in the process US drug regulators use to speed approval for drugs to fill unmet needs, federal watchdogs said in a report.
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 ...
pharmaphorum2 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 ...
pharmaphorum20 小时
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 ...
Managed Healthcare Executive8 小时
FDA Accepts BLA for Leqembi Autoinjector
If approved, subcutaneous autoinjector Leqembi will be the only Alzheimer's medication that can be administered at home. The ...
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 ...