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 an adjuvanted, recombinant varicella zoster virus (VZV) vaccine (Shingrix – GSK) for prevention of herpes zoster (shingles) in adults ≥50 years old. Shingrix is the second herpes zoster vaccine to be approved in the US; Zostavax, a live-attenuated VZV vaccine approved for the same indication, has been available since 2006.

The FDA has approved Fiasp (Novo Nordisk), a new formulation of insulin aspart, to improve glycemic control in adults with diabetes. Fiasp is described by the manufacturer as faster-acting than conventional insulin aspart (Novolog).

The FDA has approved Juluca (ViiV Healthcare/Janssen), a fixed-dose combination of the integrase strand transfer inhibitor (INSTI) dolutegravir (Tivicay) and the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine (Edurant), as a once-daily complete regimen for treatment of adults with HIV-1 infection who do not have a history of treatment failure or known substitutions associated with resistance to either drug and have been taking a stable suppressive antiretroviral regimen for ≥6 months. Dolutegravir/rilpivirine is the first complete regimen to be approved for...

View the Expanded Table: Some Drugs for Altitude Illness, Jet Lag, and Motion Sickness

Annovera (TherapeuticsMD), a contraceptive vaginal ring that releases segesterone acetate, a synthetic progestin, and ethinyl estradiol, was approved by the FDA in 2018 and is now available. It is the first product to contain segesterone and the second vaginal ring to become available in the US; NuvaRing, which delivers etonogestrel and ethinyl estradiol, was the first. Unlike NuvaRing, which requires use of a new ring each month, the Annovera ring can be used for an entire year, but it must be removed for one week each month.

The FDA has approved peanut allergen powder-dnfp (Palforzia – Aimmune) for use as oral immunotherapy to mitigate allergic reactions, including anaphylaxis, caused by accidental peanut exposure in patients with a confirmed peanut allergy. It is the first drug to be approved in the US for this indication; Viaskin Peanut, an immunotherapy patch, is under FDA review for the same indication.

The FDA has approved nasal spray formulations of the benzodiazepines diazepam (Valtoco — Neurelis) and midazolam (Nayzilam — UCB) for acute treatment of intermittent episodes of frequent seizure activity (seizure clusters). Diazepam rectal gel (Diastat, Diastat AcuDial, and generics) has been used for this indication for many years.