The FDA has approved Avlayah (tividenofusp alfa-eknm) for certain pediatric patients with Hunter syndrome, marking the first approval targeting the disease's neurologic complications and offering clinicians...
The FDA has approved Opdivo (nivolumab) in combination with doxorubicin, vinblastine, and dacarbazine for adults and pediatric patients aged 12 years and older with previously untreated stage III or IV...
The FDA has approved icotrokinra, an oral interleukin-23 receptor antagonist, for patients aged 12 years and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or...
Based on findings from the phase 3 MajesTEC-3 trial, the FDA announced the approval of teclistamab (Tecvayli) plus daratumumab hyaluronidase-fihj for adults with relapsed or refractory multiple myeloma who...
On March 3, 2026, the FDA approved the first generic of Flovent HFA (fluticasone propionate) inhalation aerosol, 44 mcg per actuation, for the maintenance treatment of asthma as prophylactic therapy in...
The FDA has approved dupilumab (Dupixent) for the treatment of allergic fungal rhinosinusitis, a rare form of chronic sinus inflammation driven by hypersensitivity to fungal organisms in the sinuses, in...
The FDA has granted traditional approval for the use of encorafenib (Braftovi) in combination with cetuximab and fluorouracil-based chemotherapy for treatment-naïve adults with BRAF V600E–mutant metastatic...
The FDA has approved a chemotherapy-free combination of acalabrutinib and venetoclax for adults with previously untreated CLL or SLL, based on a randomized phase 3 trial demonstrating a progression-free...
The FDA has authorized a first-of-its-kind therapeutic device that delivers tumor-treating fields for adults with locally advanced pancreatic cancer. The approval offers a new non-invasive option to extend...
The FDA approval expands frontline treatment options for adults with newly diagnosed multiple myeloma who are not candidates for autologous stem cell transplant, based on randomized trial data showing...
