Diana Ernst, RPh

The FDA has issued a second complete response letter to Acacia Pharma regarding the New Drug Application for Barhemsys (amisulpride injection).

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.

The FDA has approved Skyrizi (risankizumab-rzaa; AbbVie) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

The FDA has permitted for marketing the first medical device indicated for the treatment of attention deficit hyperactivity disorder ADHD.