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 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 Gimoti (Evoke), a nasal spray formulation of the dopamine-2 (D₂) receptor antagonist metoclopramide, for relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Metoclopramide (Reglan, and generics) has been available for years in conventional and orally-disintegrating tablets and in an injectable formulation. It is the only drug that is FDA-approved for treatment of diabetic gastroparesis.

Sebetralstat (Ekterly – Kalvista), an oral plasma kallikrein inhibitor, has been approved by the FDA for treatment of acute hereditary angioedema (HAE) attacks in patients ≥12 years old. It is the first oral drug to be approved in the US for this indication. The intravenous C1 esterase inhibitors (C1INHs) Berinert and Ruconest, the subcutaneous plasma kallikrein inhibitor ecallantide (Kalbitor), and the subcutaneous bradykinin B2 receptor antagonist icatibant (Firazyr) have been available for years for on-demand treatment of HAE attacks; all of these drugs except ecallantide can...

Anidulafungin (ay nid yoo la fun jin; Eraxis - Pfizer), a third intravenous echinocandin antifungal, has been approved by the FDA for treatment of esophageal candidiasis, candidemia, and other complicated Candida infections (intra-abdominal abscess or peritonitis).

The FDA has approved a fixed-dose combination of the long-acting anticholinergic glycopyrrolate and the long-acting beta2-adrenergic agonist (LABA) formoterol (Bevespi Aerosphere – AstraZeneca) for long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Glycopyrrolate/formoterol is the fourth long-acting anticholinergic/LABA combination to be approved in the US, but the first to become available in a metered-dose inhaler. Glycopyrrolate/indacaterol (Utibron Neohaler), umeclidinium/vilanterol (Anoro Ellipta), and tiotropium/olodaterol (Stiolto...

The FDA has approved cladribine (Mavenclad – EMD Serono), a purine antimetabolite, for oral treatment of adults with relapsing forms of multiple sclerosis (MS), including relapsing-remitting disease and active secondary progressive MS (SPMS), who cannot tolerate or have had an inadequate response to other drugs indicated for treatment of MS. It is not recommended for use in patients with clinically isolated syndrome (CIS). IV cladribine, which is FDA-approved for treatment of hairy cell leukemia, has been used off-label for treatment of MS.

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The FDA has approved daprodustat (Jesduvroq – GSK), a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for oral treatment of anemia due to chronic kidney disease (CKD) in adults who have been on dialysis for at least 4 months. It is the first HIF-PHI and the first oral drug to be approved in the US for this indication.

Nemolizumab (Nemluvio – Galderma), a subcutaneously injected interleukin-31 (IL-31) receptor antagonist, has been approved by the FDA for use in combination with topical corticosteroids and/or calcineurin inhibitors for treatment of moderate to severe atopic dermatitis in patients ≥12 years old whose disease is not adequately controlled with topical prescription drugs. It is the first IL-31 receptor antagonist to be approved in the US for this indication. Nemolizumab was approved earlier for treatment of prurigo nodularis in adults.