The FDA has approved a new plasma-derived von Willebrand factor/Factor VIII concentrate (Wilate – Octapharma) for treatment of spontaneous and trauma-induced bleeding episodes in patients with von Willebrand disease.

The FDA has approved the Maestro Rechargeable System (EnteroMedics), a subcutaneously implanted device, for use in adults who have not been able to lose weight with a weight loss program within the past 5 years and who have a body mass index (BMI) of 40 to 45, or a BMI ≥35 and at least one obesity-related comorbidity.

The FDA has approved the immune checkpoint inhibitor atezolizumab (Tecentriq – Genentech) for treatment of locally advanced or metastatic urothelial carcinoma and metastatic non-small cell lung cancer (NSCLC) that have progressed during or following platinum-based chemotherapy. Atezolizumab is the first programmed death-ligand 1 (PD-L1) blocking antibody to become available in the US. Two other immune checkpoint inhibitors, the programmed death receptor-1 (PD-1) inhibitors nivolumab (Opdivo) and pembrolizumab (Keytruda), are also approved for treatment of metastatic NSCLC, and...

The FDA has approved a subcutaneously administered 20% solution of human immune globulin (Cuvitru – Shire) for replacement therapy in patients ≥2 years old with a primary humoral immunodeficiency. Hizentra (CSL Behring), another subcutaneously administered 20% immune globulin solution, was approved in 2010 for the same indication. The IgG component of Cuvitru is similar to that of Gammagard Liquid and HyQvia, two subcutaneously administered 10% immune globulin formulations also manufactured by Shire and approved for treatment of primary...

The FDA has approved intravenously administered recombinant von Willebrand factor (Vonvendi - Shire) for adults with von Willebrand disease (VWD) who require on-demand treatment and control of bleeding episodes. It is the first recombinant von Willebrand factor (VWF) product to become available in the US.

The FDA has approved a fixed-dose combination of meropenem, a carbapenem antibiotic, and vaborbactam, a new beta-lactamase inhibitor (Vabomere – Melinta), for IV treatment of adults with complicated urinary tract infections (UTIs) that are proven or strongly suspected to be caused by Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae spp. complex. Meropenem (Merrem, and generics) has been approved for years for treatment of complicated skin and skin structure infections, intra-abdominal infections, and bacterial meningitis. Resistance to meropenem and other...

The FDA has approved the new aminoglycoside antibiotic plazomicin (Zemdri – Achaogen) for IV treatment of adults with complicated urinary tract infections (cUTIs). Plazomicin is active against multi-drug- resistant Enterobacteriaceae, including strains resistant to other aminoglycosides.

An oral formulation of testosterone undecanoate (Jatenzo – Clarus) has been approved by the FDA for treatment of adult men with conditions associated with a deficiency of endogenous testosterone, such as Klinefelter syndrome, orchiectomy, toxic damage from chemotherapy or alcohol, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Jatenzo is not approved for treatment of low testosterone levels solely due to aging. It is the first oral testosterone formulation to be approved in the US.

Glycopyrrolate (Robinul, and others), a synthetic muscarinic receptor antagonist, has been used off-label for many years for treatment of excessive drooling in patients with Parkinson’s disease, in patients taking clozapine for schizophrenia, and in developmentally disabled children.1-3 It has now been approved by the FDA as Cuvposa (Shionogi) for use specifically in children 3-16 years old with severe chronic drooling due to a neurologic condition, such as cerebral palsy. It is being marketed as an oral solution, which will permit more precise weight-based dosing than was possible with the...

The US Advisory Committee on Immunization Practices (ACIP) now recommends routine immunization with 13-valent pneumococcal conjugate vaccine (PCV13; Prevnar 13), in addition to the 23-valent pneumococcal polysaccharide vaccine (PPSV23; Pneumovax 23), for all adults ≥65 years old.1An unpublished, randomized, double-blind trial (CAPiTA) in about 85,000 adults ≥65 years old found that vaccination with PCV13 reduced first episodes of vaccine-type community-acquired pneumonia and invasive pneumococcal disease by 46% and 75%, respectively, compared to placebo.2Adults ≥65 years old who...