The first FcRn blocker for both adult and pediatric generalized myasthenia gravis has been approved by the FDA, based on data showing sustained symptom improvement and IgG reduction in clinical trials.
Phase III trial results show that once-daily brensocatib reduces pulmonary exacerbations and slows lung function decline in patients with bronchiectasis.
The FDA approved Rinvoq (upadacitinib) as the first and only oral Janus kinase inhibitor for the treatment of giant cell arteritis in adults, providing a steroid-sparing option for achieving sustained remission.
The FDA has issued a safety alert on compounded topical finasteride products, citing adverse events and emphasizing the lack of regulatory approval or safety evaluation.
The FDA has authorized Minder, the first implantable continuous electroencephalogram monitor, offering long-term brain activity tracking for improved epilepsy management, available in the U.S.
The FDA and HHS announced plans to eliminate petroleum-based synthetic food dyes, citing potential health risks and aligning with global safety standards.