The U.S. FDA cleared 21 drugs for market in March, topping 16 approvals granted in February and 12 in January. That brought the first quarter (Q1) total to 49 approvals, just one short of the 50 logged in Q1 2024, making it the second-highest Q1 count in BioWorld’s records.

Nearly three weeks into the job, U.S. FDA Commissioner Marty Makary provided a comprehensive overview of his vision for the much-reduced agency, even as he’s taking first steps to implement his agenda.

Watchers of the percolating myasthenia gravis space are waiting eagerly for data from Dianthus Therapeutics Inc.’s phase II Magic study testing DNTH-103, an active C1s inhibitor, compared to placebo in patients with anti-AChR-positive generalized disease.

The U.S. FDA issued a complete response letter in October 2023 for Dupixent (dupilumab) in treating chronic hives but has now approved the monoclonal antibody for the indication. The approval makes Dupixent the first targeted biologic the agency has approved in the past 11 years for chronic spontaneous urticaria.