Steve Duffy

Weight loss treatment has approval expanded; Paxlovid with Emergency Use Authorized label must be disposed of; psychedelic gets Breakthrough therapy designation; Advisory Committee announce meeting to discuss Alzheimer treatment; ALS treatment trial results.

Drug Pharmacologic Class Proposed Indication Status Cardiovascular Disease Acoramidis (BridgeBio Pharma) Small molecule designed to stabilize tetrameric transthyretin Treatment of patients with transthyretin amyloid cardiomyopathy. NDA accepted CardiolRx (Cardiol Therapeutics) Cannabidiol Treatment of recurrent pericarditis. Orphan Drug designation Dermatologic Disorders Nemolizumab (Galderma) Humanized monoclonal antibody that antagonizes IL-31 receptor alpha Treatment of prurigo nodularis and…

The table below is a review of notable updates that occurred in February 2024 for investigational products in development (not an inclusive list). Click on the status to view our full coverage.

Over-the-counter birth control pill to be available in the coming weeks; first over-the-counter continuous glucose monitor to be available starting this summer; the 2024-2025 US influenza season vaccine will be trivalent; LSD granted Breakthrough Therapy for treatment of generalized anxiety disorder; interchangeable biosimilars to Prolia and Xgeva approved. 

A 12-year-old boy is referred for evaluation of a skin lesion located on his right inner thigh. The growth has been present for several months and has remained asymptomatic. He is in good health and has no similar lesions elsewhere on the body. The family history is negative for genodermatoses. Examination of the lesion reveals a reddened 1.0cm firm nodule.

Drug Pharmacologic Class Indication More Information Allergic Disorders Xolair (omalizumab) Anti-immunoglobulin E (IgE) antibody For the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to 1 or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy. Xolair Approved for Adults and Pediatric Patients With…