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FDA Alerts

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
FDA alert
FDA alert
11/14/2023

Jessica Ganga

Jessica Ganga
The FDA has approved the first biosimilar treatment for patients living with relapsing forms of multiple sclerosis.
11/14/2023
FDA Alert
FDA Alert
11/13/2023
Tirzepatide is now approved for a new indication. The dual GIP/GLP-1 agonist was previously approved for treating type 2 diabetes in May 2022.
11/13/2023
fda alert
fda alert
10/19/2023

Leigh Precopio

Leigh Precopio
The FDA approved the use of quizartinib for certain patient populations with acute myeloid leukemia in July 2023.
10/19/2023
FDA Alert
FDA Alert
10/04/2023

Jessica Ganga

Jessica Ganga
Following two randomized studies, the FDA has approved zuranolone for the treatment of postpartum depression in adults—the first if its kind.
10/04/2023
FDA Alert
FDA Alert
09/28/2023

Anthony Calabro, MA

Anthony Calabro, MA
The FDA approved the second over-the-counter nasal spray with the goal of increasing access to products that can rapidly reverse the effects of opioid overdose.
09/28/2023