Sarepta, Biogen drugs with accelerated approval under fire in FDA report
A report from the U.S. FDA's Office of Inspector General is calling into question the thoroughness of the agency's ...
verywellhealth9h
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.com16h
FDA To Review Under the Skin Weekly Autoinjector For Biogen/Eisai's Alzheimer's Drug Leqembi
FDA sets August 31 ... Alerts for Your Portfolio Leqembi is indicated for Alzheimer’s disease in patients with Mild Cognitive ...
pharmaphorum19h
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 ...
Becker's Hospital Review5d
2025's most anticipated drug approvals: GoodRx
Stay updated on the latest potential FDA drug approvals in 2025, including an expanded label for Ozempic and new, nonopioid painkillers.
BioSpace8d
5 FDA Decisions to Watch in Q1
Among the FDA’s pending decisions for this quarter are Vertex’s non-opioid pain drug and Sanofi’s RNA interference therapy ...
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 ...
Eisai and Biogen’s subcutaneous Leqembi set for FDA review
Eisai and Biogen are one step away from deploying a more convenient version of their jointly developed Alzheimer’s treatment ...
STAT4d
Patrizia Cavazzoni, head of FDA’s drug center, to leave the agency
Patrizia Cavazzoni, leader of the FDA's Center for Drug Evaluation and Research, is leaving the agency on Jan. 18.
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 ...
Becker's Hospital Review11d
Most influential drug approvals of 2024: GoodRx
Discover the top 19 most notable drugs approved by the FDA in 2024, including Dupixent for COPD and FluMist for self-administration. See the full list here.