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...
In 6-year long-term follow-up of adults with severe or moderately severe hemophilia B, single-dose fidanacogene elaparvovec maintained FIX activity and low treated annualized bleeding rates.
In the phase 3a REIMAGINE 1 trial, once-weekly cagrilintide–semaglutide reduced HbA1c vs placebo at 40 weeks in adults with early-stage type 2 diabetes that was inadequately controlled with diet and...
A phase 3 randomized trial found that Mim8 prophylaxis significantly reduced bleeding rates compared with on-demand therapy and clotting factor prophylaxis in patients with hemophilia A with or without...
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...
