Insulin Lispro Injection, an authorized generic version of Humalog U-100, has been made available by Lilly at a 50% lower list price.
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for Invokana (canagliflozin; Janssen) to reduce the risk of end-stage renal disease (ESRD) and renal or cardiovascular (CV) death in adults with type 2 diabetes (T2D) and chronic kidney disease (CKD).
When used as needed, the combination of budesonide-formoterol was found to be superior to albuterol for the prevention of asthma exacerbations in patients with mild asthma.
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 National Lipid Association (NLA) has released updated guidance for clinicians on identifying patients for which proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor therapy would provide reasonable value. Currently, two PCSK9 therapies have been approved by the Food and Drug Administration. Alirocumab is indicated as an adjunct to diet, alone or in combination with…
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.
The FDA has approved Venclexta in combination with Gazyva for the treatment of patients with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.
The Food and Drug Administration has approved Bavencio (avelumab; EMD Serono), a programmed death-ligand 1 (PD-L1) blocking antibody, in combination with Inlyta (axitinib; Pfizer), a kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
Top-line results were announced from a phase 3 study evaluating the safety and efficacy of abrocitinib, an oral Janus kinase 1 (JAK1) inhibitor, for the treatment of moderate to severe atopic dermatitis in patients ≥12 years old.
The Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee recently voted on 2 investigational therapies being developed by Daiichi Sankyo: pexidartinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT), and quizartinib for the treatment of adults with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML).
