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...
The FDA approved two new oral therapies to treat uncomplicated urogenital gonorrhea. Both treatments demonstrated comparable effectives when compared to standard treatment.
The US Food and Drug Administration has approved mitapivat tablets for the treatment of anemia in adults with alpha- or beta-thalassemia, offering a new oral option supported by randomized clinical trial...
The FDA has cleared a once-daily oral semaglutide treatment for adults with obesity or overweight and weight-related conditions, based on phase 3 OASIS 4 trial results demonstrating significant mean weight...
