FDA approved new therapies, including first-in-class treatments

The FDA approved several new therapies in Q2 2025, including the first treatments for IgG4-related disease and alkaptonuria, expanding treatment options for rare diseases. These approvals included atrasentan for IgA nephropathy, beremagene geperpavec gene therapy for recessive dystrophic epidermolysis bullosa, and upadacitinib for giant cell arteritis, offering new options for various conditions. Additionally, lenacapavir for HIV prevention was approved. Other approvals included mepolizumab for eosinophilic COPD, roflumilast foam for psoriasis, and clesrovimab for RSV prevention, reflecting a trend toward targeted therapies. These approvals highlight advancements in precision medicine.