FDA News

The Access p-Tau217/β-Amyloid 1-42 plasma ratio blood test is designed to help identify patients with amyloid pathology associated with AD.

Georgetown University memory disorders expert R Scott Turner, PhD, MD, reviews the science behind approval of lecanemab for monthly maintenance dosing of lecanemab.

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Once every four weeks maintenance dosing of lecanemab may be easier for patients and care partners to continue treatment.

These test panels allow clinicians to diagnose multiple STIs from a single specimen, with results available in about 20 minutes.

The approval of esketamine follows an FDA Priority Review and is based on data showing that esketamine alone demonstrated rapid and superior improvement in depressive symptoms compared with placebo.

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

Mineralys Therapeutics also expects topline data from its phase 2 study of lorundrostat for the treatment of uncontrolled hypertension or resistant hypertension when used as an add-on therapy.

The agency estimates that limiting nicotine levels could lead to 1.8 million fewer tobacco-related deaths by 2060 and health care savings of $1.1 trillion a year over the next 40 years.

Marketed as Omvoh, the therapy is already approved as a first-in-class treatment for moderately to severely active ulcerative colitis.