Best Read FDA Approval Stories in 2023

FDA Approves First Anti-inflammatory Drug for Cardiovascular Disease

In June 2023, the FDA approved Lodoco to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients. Lodoco is the first drug approved to target inflammation that is an underlying cause of atherosclerotic cardiovascular disease.

FDA Approves Pfizer’s Alopecia Drug

The FDA in June 2023 approved Pfizer’s Litfulo (ritlecitinib), a once-daily oral treatment, for people 12 years of age and older with severe alopecia. It has an annual list price of Litfulo is $49,000.

FDA Approves First Drug for Geographic Atrophy Due to AMD

The FDA approved Syfovre in February 2023 with a list price of $2,190 per vial,

New Pediatric Growth Hormone Therapy Costs $8,300 Monthly

Ngenla (somatrogon-ghla), approved by the FDA in June 2023 is a once-weekly, human growth hormone analog for pediatric patients 3 years and older who have growth failure due to inadequate secretion of endogenous growth hormone.

FDA Approves Xdemvy for Eye Infection Caused by Mites

Xdemvy, approved in July, is the first treatment that directly targets the mites involved in the Demodex blepharitis. It has list price of $1,850 per prescription.

GSK’s Arexvy is First RSV Vaccine Approved for Older Adults

Approved in May, Arexvy prevents lower respiratory tract disease (LRTD) caused by RSV in individuals 60 years of age and older.