The FDA has approved pembrolizumab (Keytruda – Merck), a human programmed death receptor-1 (PD-1) blocking antibody, for treatment of unresectable or metastatic melanoma that has progressed following treatment with ipilimumab (Yervoy) and, if the patient is BRAF V600 mutation positive, a BRAF inhibitor. It is the fi rst PD-1 inhibitor to be marketed in the US. Nivolumab, another PD-1 inhibitor, is available in Japan. Pembrolizumab was previously known as lambrolizumab.

Bepotastine besilate 1.5% ophthalmic solution (Bepreve - ISTA Pharmaceuticals), an H₁-antihistamine, has been approved by the FDA for topical treatment of itching associated with allergic conjunctivitis in patients ≥2 years old. Bepotastine was first developed in an oral systemic formulation and has been used as such for treatment of allergic rhinitis in Japan.

The FDA has approved Xultophy 100/3.6 (Novo Nordisk), a fixed-ratio combination of insulin degludec and the GLP-1 (glucagon-like peptide-1) receptor agonist liraglutide, for once-daily treatment of adults with type 2 diabetes inadequately controlled on basal insulin (<50 units daily) or liraglutide (≤1.8 mg daily).

A new 2023-2024 formulation of the adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax that was developed to more closely target currently circulating SARS-CoV-2 variants has been made available in the US under an FDA Emergency Use Authorization (EUA) for use in persons ≥12 years old. The original formulation of the Novavax vaccine is no longer authorized for use in the US. In September, updated formulations of the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) were licensed by the FDA for use in persons ≥12 years old and...

The FDA has approved lixisenatide (Sanofi), a short-acting injectable GLP-1 (glucagon-like peptide-1) receptor agonist, for once-daily treatment of adults with type 2 diabetes, both alone (Adlyxin) and in a fixed-ratio combination with insulin glargine (Soliqua 100/33). Lixisenatide has been available since 2013 in many other countries as Lyxumia. It is the fifth GLP-1 receptor agonist to be approved in the US.

Veltin Gel (Stiefel), a fixed-dose combination of the antibiotic clindamycin phosphate 1.2% and the retinoid tretinoin 0.025%, has been approved by the FDA for topical treatment of acne vulgaris in patients ≥12 years old. Another product containing the same active ingredients (Ziana) has been on the market since 2006.

The FDA has approved the sodium-glucose co-transporter 2 (SGLT2) inhibitor ertugliflozin (Merck) for treatment of adults with type 2 diabetes, both alone (Steglatro) and in fixed-dose combinations with metformin (Segluromet) and sitagliptin (Steglujan). Ertugliflozin is the fourth SGLT2 inhibitor to be approved in the US. All four are available in combination with metformin and three are available in combination with a dipeptidyl peptidase-4 (DPP-4) inhibitor (see Table 3).

The FDA has approved Simbrinza (Alcon), an ophthalmic combination of the carbonic anhydrase inhibitor brinzolamide and the selective alpha₂-adrenergic receptor agonist brimonidine, for reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Simbrinza is the first product to combine drugs from these 2 classes.

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.