The FDA has approved Twirla (Agile Therapeutics), a transdermal contraceptive patch containing the estrogen ethinyl estradiol and the progestin levonorgestrel, for use in women with a BMI <30 kg/m². It is the second contraceptive patch to become available in the US; Xulane, a patch that delivers ethinyl estradiol and the progestin norelgestromin, has been available since 2014.

The centuries-old anti-inflammatory drug colchicine (Colcrys, and others) is FDA-approved for prophylaxis and treatment of gout flares and for treatment of familial Mediterranean fever. It is also used off-label to treat pericarditis, and in recent years has been investigated for reduction of cardiovascular risk in patients with coronary artery disease (CAD).

Finerenone (Kerendia – Bayer), an oral nonsteroidal mineralocorticoid receptor antagonist (MRA), has been approved by the FDA to reduce the risk of sustained eGFR decline, end-stage renal disease, nonfatal MI, hospitalization for heart failure (HF), and cardiovascular death in adults with chronic kidney disease (CKD) associated with type 2 diabetes. It is the first nonsteroidal MRA to be approved in the US.

The FDA has approved dasiglucagon (Zegalogue – Zealand) for subcutaneous (SC) treatment of severe hypoglycemia in patients ≥6 years old with diabetes. Dasiglucagon is the third glucagon product to be marketed in the US that does not require reconstitution before administration; Gvoke, a SC formulation approved for use in patients ≥2 years old, and Baqsimi, an intranasal powder approved for use in patients ≥4 years old, have been available since 2019. Injectable glucagon emergency kits (GlucaGen HypoKit, and generics) have been available for years, but they require...

The FDA has approved remimazolam (Byfavo – Acacia Pharma), an ultra-short-acting IV benzodiazepine, for induction and maintenance of sedation in adults undergoing procedures of up to 30 minutes' duration.

The 1.5% cream formulation of the Janus kinase (JAK) inhibitor ruxolitinib (Opzelura – Incyte) has been approved by the FDA for topical treatment of nonsegmental vitiligo (NSV) in patients ≥12 years old. Opzelura is the first product to be approved by the FDA for this indication. It was previously approved for treatment of atopic dermatitis.

The FDA has approved Relyvrio (Amylyx), a fixed-dose combination of sodium phenylbutyrate and taurursodiol, for treatment of amyotrophic lateral sclerosis (ALS). Sodium phenylbutyrate (Buphenyl, and others) has been available by prescription for years for treatment of urea cycle disorders. Taurursodiol (tauroursodeoxycholic acid), a derivative of ursodiol, is an over-the-counter bile acid supplement claimed to have neuroprotective benefits. Relyvrio is the third drug to be approved in the US for treatment of ALS; riluzole (Rilutek, and others) and edaravone (Radicava, Radicava...

Teplizumab-mzwv (Tzield – Provention Bio), an anti-CD3 monoclonal antibody, has been approved by the FDA to delay the onset of stage 3 type 1 diabetes in patients ≥8 years old who have stage 2 type 1 diabetes. It is the first drug to become available in the US that delays the onset of type 1 diabetes.

The FDA has approved oral and injectable formulations of the HIV-1 capsid inhibitor lenacapavir (Sunlenca – Gilead) for use with other antiretroviral drugs to treat multidrug-resistant HIV-1 infection (MDR-HIV) in heavily treatment-experienced adults whose current regimen is failing. Lenacapavir is the third drug to be approved exclusively for treatment of MDR-HIV; the intravenously administered CD4-directed antibody ibalizumab-uiyk (Trogarzo) and the orally administered HIV-1 gp120-directed attachment inhibitor fostemsavir (Rukobia) were approved earlier.

The oral sphingosine 1-phosphate (S1P) receptor modulator etrasimod (Velsipity – Pfizer) has been approved by the FDA for treatment of moderately to severely active ulcerative colitis in adults. It is the second oral S1P receptor modulator to be approved in the US for this indication; ozanimod (Zeposia) was the first.