The FDA has approved the mitogen-activated extracellular signal-regulated kinase (MEK) inhibitor cobimetinib (Cotellic – Genentech) for use in combination with the BRAF kinase inhibitor vemurafenib (Zelboraf) for treatment of unresectable or metastatic melanoma with a BRAF V600E or V600K mutation.

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...

Obeticholic acid (Ocaliva – Intercept), a farnesoid X receptor agonist, has been approved by the FDA for treatment of primary biliary cholangitis; it is indicated for use in combination with ursodeoxycholic acid (ursodiol, UDCA; Urso, and others) in adults with an inadequate response to UDCA and as monotherapy in adults unable to tolerate UDCA. Obeticholic acid is the second drug to be approved for this indication; UDCA was the first.

The FDA has approved dupilumab (Dupixent – Sanofi/Regeneron), a subcutaneously-injected fully human monoclonal antibody, for treatment of adults with moderate to severe atopic dermatitis (eczema) that has not responded to topical therapies. It can be used with or without topical corticosteroids.

The FDA has approved brodalumab (Siliq – Valeant), an injectable human interleukin (IL)-17A receptor antagonist, for treatment of adults with moderate to severe plaque psoriasis who have failed to respond to other systemic therapies. Brodalumab is the third IL-17A antagonist to be approved in the US for this indication; secukinumab (Cosentyx) and ixekizumab (Taltz) were approved earlier.

The FDA has approved Duzallo (Ironwood), a fixed-dose combination of the uric acid transporter 1 (URAT1) inhibitor lesinurad (Zurampic) and the xanthine oxidase inhibitor allopurinol (Zyloprim, and generics), for once-daily treatment of gout-associated hyperuricemia in patients who have not achieved target serum uric acid levels with allopurinol alone.

The FDA has approved the opioid receptor antagonist naldemedine (Symproic – Shionogi) for treatment of opioid-induced constipation (OIC) in adults with chronic noncancer pain. Naldemedine is the third oral peripherally-acting mu-opioid receptor antagonist (PAMORA) to be approved for this indication; naloxegol (Movantik) and methylnaltrexone (Relistor) were approved earlier.

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 Janus kinase (JAK) inhibitor baricitinib (Olumiant – Lilly) for oral treatment of adults with moderately to severely active rheumatoid arthritis (RA) that has not responded adequately to one or more tumor necrosis factor (TNF) inhibitors. Baricitinib is the second JAK inhibitor to be approved for treatment of RA; tofacitinib (Xeljanz, Xeljanz XR) was the first.

A lidocaine 1.8% patch (ZTlido – Scilex) has been approved by the FDA for treatment of pain associated with postherpetic neuralgia (PHN). A lidocaine 5% patch (Lidoderm, and generics) was approved earlier for the same indication and has been used off-label for treatment of other types of localized pain. Both of these patches are available only by prescription. Lidocaine 4% patches (Aspercreme, IcyHot, and others) are available over the counter for back, neck, shoulder, and joint pain.