The FDA has approved peramivir (Rapivab – BioCryst), an IV neuraminidase inhibitor administered as a single dose, for treatment of acute uncomplicated influenza in patients ≥18 years old who have had symptoms for no more than 2 days. Peramivir was available temporarily in the US during the 2009-2010 influenza season under an emergency use authorization for treatment of hospitalized patients. It has been available in some Asian countries since 2010. Peramivir is the third neuraminidase inhibitor to be approved in the US. Oseltamivir (Tamiflu), which is taken orally, and zanamivir...

The FDA has approved isavuconazonium sulfate (Cresemba – Astellas) for intravenous and oral treatment of invasive aspergillosis and invasive mucormycosis in adults. Isavuconazonium sulfate is a prodrug of isavuconazole, a broad-spectrum triazole antifungal.

The FDA has approved rifamycin (Aemcolo – Cosmo/ Aries), a minimally absorbed oral antibiotic, for treatment of adults with travelers' diarrhea (TD) caused by noninvasive strains of Escherichia coli. It is not recommended for treatment of diarrhea that is complicated by fever and/or bloody stools. Topical and injectable formulations of rifamycin have been used in Europe for other indications for many years.

The FDA has approved loteprednol etabonate ophthalmic suspension 0.25% (Eysuvis – Kala) for short-term treatment (≤2 weeks) of dry eye disease. It is the first ocular corticosteroid to be approved for this indication. Other formulations of loteprednol are approved for treatment of steroid-responsive ocular inflammatory conditions, inflammation after ocular surgery, and seasonal allergic conjunctivitis.

The FDA has licensed MenQuadfi (Sanofi Pasteur), a quadrivalent polysaccharide conjugate vaccine that uses tetanus toxoid as a protein carrier, for prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y (MenACWY) in persons ≥2 years old.

A 2024-2025 formulation of the Novavax adjuvanted protein subunit COVID-19 vaccine that more closely targets currently circulating SARS-CoV-2 variants is available now under an FDA Emergency Use Authorization (EUA) for use in persons ≥12 years old. The 2024-2025 formulations of the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) were licensed by the FDA last month for use in persons ≥12 years old and made available under EUAs for use in persons 6 months to 11 years old.

In recent years, several new drugs have been approved by the FDA for use in multiple sclerosis (MS), and many others are in the pipeline. Most recently, teriflunomide (Aubagio – Genzyme) became the second oral drug to be approved by the FDA for treatment of relapsing forms of MS.

The FDA has approved baloxavir marboxil (Xofluza – Shionogi/Genentech), the first polymerase acidic (PA) endonuclease inhibitor, for single-dose, oral treatment of acute uncomplicated influenza in patients ≥12 years old. Baloxavir is the first drug with a new mechanism of action to be approved for treatment of influenza in almost 20 years.

Fungal infections of the fingernails or toenails can persist for months or years despite topical and systemic antimicrobial therapy. The FDA has cleared several short-pulse laser systems for treatment of this mainly cosmetic disorder.

The FDA has approved crofelemer (kroe fel’ e mer; Fulyzaq – Salix), a chloride channel inhibitor derived from the red sap of the South American plant Croton lechleri, for symptomatic relief of noninfectious diarrhea in patients with HIV taking antiretroviral drugs. It is the first drug approved for relief of antiretroviral-induced diarrhea and the first oral botanical drug approved by the FDA.