FDA Approves Nayzilam Nasal Spray to Treat Seizure Clusters
The Food and Drug Administration (FDA) has approved Nayzilam (midazolam) nasal spray for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity
The Food and Drug Administration (FDA) has approved Nayzilam (midazolam) nasal spray for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity
The FDA has approved Fragmin, a low molecular weight heparin, for the treatment of symptomatic venous thromboembolism to reduce the recurrence of VTE in pediatric patients 1 month of age and older.
Three lots of Promacta for oral suspension 12.5mg are being recalled due to possible peanut flour contamination at a third-party manufacturer.
The FDA has approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) for the treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.
The FDA has issued a second complete response letter to Acacia Pharma regarding the New Drug Application for Barhemsys (amisulpride injection).
The Food and Drug Administration (FDA) has approved Dengvaxia (dengue tetravalent vaccine, live; Sanofi) for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4.
A new Boxed Warning will be required in the prescribing information for several insomnia medications following reports of serious injuries and deaths associated with complex sleep behaviors where patients engaged in activities while not fully awake.
The FDA has approved Praluent (alirocumab; Sanofi and Regeneron), a PCSK9 inhibitor, to reduce the risk of myocardial infarction (MI), stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.
The New Drug Application (NDA) for the long-acting injectable formulation of rilpivirine + cabotegravir (Janssen and ViiV Healthcare) for patients with HIV-1 infection has been submitted to the Food and Drug Administration (FDA).
The Food and Drug Administration (FDA) has approved the intravenous (IV) formulation of Benlysta (belimumab; GlaxoSmithKline) for the treatment of pediatric patients ≥5 years old with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy.