July 2026 included several FDA drug and biologic approvals across a range of therapeutic areas. This timeline highlights the key alerts our publication covered throughout the month, giving readers a quick,...
The FDA approved subcutaneous isatuximab-irfc (Sarclisa Escena, Sanofi-Aventis US LLC) for multiple myeloma treatment regimens across relapsed, refractory, and newly diagnosed disease settings.
The FDA expanded approval of exagamglogene autotemcel (Casgevy) for patients aged 2 years and older with sickle cell disease and recurrent vaso-occlusive crises or transfusion-dependent β-thalassemia.
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The FDA approval expands the use of marstacimab-hncq (Hympavzi; Pfizer Inc.) for routine prophylaxis to prevent or reduce bleeding episodes in additional pediatric and inhibitor-positive hemophilia A and B...
The FDA approved oral decitabine and cedazuridine (Inqovi) tablets with venetoclax for adults with newly diagnosed acute myeloid leukemia who are aged 75 years or older or have comorbidities that preclude...
An open-label, randomized trial found that daratumumab and hyaluronidase-fihj administered subcutaneously improved the risk of disease progression or death in patients with multiple myeloma. As a result,...
The FDA has approved concizumab-mtci, a daily subcutaneous treatment to reduce bleeding for patients with hemophilia who have clotting factor inhibitors.
The FDA has approved a novel therapy for patients with hemophilia A or B without inhibitors. Clinical trials showed it significantly reduces bleeding episodes by targeting a new protein in the blood...
The FDA has approved a novel therapy for patients with hemophilia A or B without inhibitors. Clinical trials showed it significantly reduces bleeding episodes by targeting a new protein in the blood...
