FDA News

The adcomm meeting is expected to happen in the first half of 2025, and means the FDA expects to miss the target PDUFA date.

Buntanetap is an oral molecule designed to inhibit the production of multiple neurotoxic proteins and is under investigation for treatment of Alzheimer Disease, Parkinson’s Disease, and other neurodegenerative diseases.

The FDA approved the addition of Guillain-Barré syndrome warnings for Abrysvo and Arexvy, citing postmarketing data suggesting an increased risk.

In an unusual step, the agency's draft guidance recommends the efficacy benchmark for drug approval while emphasizing clinical trial structure and cohort development.

Johnson & Johnson's posdinemab aims to slow tau pathology in early and preclinical Alzheimer’s disease populations.

Your daily dose of the clinical news you may have missed.

Your daily dose of the clinical news you may have missed.

In November 2024, an FDA advisory committee said the benefits of sotagliflozin do not outweigh the risks in adults with type 1 diabetes and chronic kidney disease.

The FDA has approved the first generic once-daily GLP-1 injection for the improvement of glycemic control for type 2 diabetes in patients 10 years and up.

The black box warning, the agency's most prominent alert, follows earlier additions to the original fezolinetant label about hepatic injury and regular LFT testing.