FDA Alerts

The FDA previously approved lisocabtagene maraleucel as a second-line treatment option for adult patients with large B-cell lymphoma in June 2022.

The FDA approved givinostat, a nonsteroidal oral medication, for treating patients 6 years of age or older with Duchenne muscular dystrophy.

The FDA has approved sotatercept-csrk, the first activin signaling inhibitor therapy, for the management of patients with pulmonary arterial hypertension (PAH). Based on the Phase 3 STELLAR trial,...

The FDA approved resmetirom for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis with moderate-to-advanced liver fibrosis.

On March 8, the FDA approved the injectable weight loss medication, semaglutide, for reducing the risk of cardiovascular events such as heart attack, stroke, and cardiovascular death in adults with heart...

The FDA approved two gene therapies, the first of their kind, to treat patients aged 12 years and older with sickle cell disease.

The FDA approved irinotecan liposome with oxaliplatin, fluorouracil, and leucovorin as a first-line regimen for the management of patients with metastatic pancreatic adenocarcinoma.

The FDA approved the first treatment for patients with congenital thrombotic thrombocytopenic purpura (cTTP), which is a rare and life-threatening blood clotting disorder that may be fatal if left...

The once-monthly RNA interference injection medication received FDA approval based on results from the phase II PHYOX2 clinical trial and phase III PHYOX3 extension study.

The FDA approved pirtobrutinib for adults with either chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least two prior lines of therapy.