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FDA Alerts

FDA ALERT
FDA ALERT
04/12/2024

Jessica Bard

Jessica Bard
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,...
04/12/2024
FDA Alert
FDA Alert
03/21/2024

Anthony Calabro, MA

Anthony Calabro, MA
The FDA approved resmetirom for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis with moderate-to-advanced liver fibrosis.
03/21/2024
FDA Alert
FDA Alert
03/21/2024

Anthony Calabro, MA

Anthony Calabro, MA
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...
03/21/2024
FDA Alert
FDA Alert
03/19/2024

Jessica Ganga

Jessica Ganga
The FDA approved two gene therapies, the first of their kind, to treat patients aged 12 years and older with sickle cell disease.
03/19/2024
FDA Alert
FDA Alert
03/04/2024

Anthony Calabro, MA

Anthony Calabro, MA
The FDA approved irinotecan liposome with oxaliplatin, fluorouracil, and leucovorin as a first-line regimen for the management of patients with metastatic pancreatic adenocarcinoma.
03/04/2024
FDA Alert
FDA Alert
02/07/2024

Jessica Ganga

Jessica Ganga
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...
02/07/2024
FDA ALERT
FDA ALERT
01/29/2024

Anthony Calabro, MA

Anthony Calabro, MA
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.
01/29/2024
FDA ALERT
FDA ALERT
01/26/2024

Anthony Calabro, MA

Anthony Calabro, MA
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.
01/26/2024
FDA ALERT
FDA ALERT
11/30/2023

Anthony Calabro, MA

Anthony Calabro, MA
The FDA approved ustekinumab-auub as an interchangeable biosimilar with ustekinumab for multiple inflammatory diseases.
11/30/2023
FDA ALERT
FDA ALERT
11/15/2023

Jessica Ganga

Jessica Ganga
In late September, the FDA approved the first biosimilar to tocilizumab to treat adult and pediatric patients with various indications of arthritis.
11/15/2023