Tyzavan is the first FDA-approved vancomycin formulation available at room temperature that requires no compounding, thawing, or dilution, enabling faster treatment in time-critical infections like sepsis.
Bavarian Nordic’s freeze-dried Jynneos vaccine offers logistical advantages over the liquid-frozen version, supporting long-term U.S. stockpiling and public health preparedness.
The FDA has approved Zynyz (retifanlimab-dlwr) as the first programmed death receptor-1 inhibitor for first-line treatment of advanced squamous cell carcinoma of the anal canal.
April’s FDA approvals feature first-in-class therapies, targeted biologics, expanded indications, and innovative delivery systems across allergy, endocrinology, rheumatology, oncology, infectious diseases, and more.
May’s FDA approvals include the first at-home HPV test, a blood-based Alzheimer’s diagnostic, biosimilars, AI-enabled imaging tools, and novel therapies across cardiology, pulmonology, neurology, gastroenterology, and more.