The FDA has approved Dovato (ViiV), a fixed-dose combination of the integrase strand transfer inhibitor (INSTI) dolutegravir (Tivicay) and the nucleoside reverse transcriptase inhibitor (NRTI) lamivudine (Epivir, and generics), as a once-daily complete regimen for treatment of adults with HIV-1 infection who are antiretroviral-treatment naive and have no known substitutions associated with resistance to either drug. Dolutegravir/lamivudine is the first complete regimen to be approved by the FDA for initial treatment of HIV-1 infection that contains 2 rather than 3 antiretroviral...

A 0.24% ophthalmic solution of the second-generation H₁-antihistamine cetirizine (Zerviate – Eyevance) is now available by prescription for treatment of ocular itching associated with allergic conjunctivitis in patients ≥2 years old. Oral cetirizine (Zyrtec, and others), which is used for treatment of allergic conjunctivitis and rhinitis, has been available over the counter (OTC) for years.

The FDA has approved cenobamate (Xcopri – SK Life Science) for oral treatment of partial-onset (focal) seizures in adults.

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 approved mannitol powder for oral inhalation (Bronchitol – Chiesi) as add-on maintenance treatment to improve pulmonary function in adults with cystic fibrosis (CF). This product has been available in Europe for the same indication since 2012. Another formulation of mannitol inhalation powder (Aridol) is approved in the US for assessment of bronchial hyperresponsiveness.

Elafibranor (Iqirvo – Ipsen), a peroxisome proliferator-activated receptor (PPAR) agonist, has been granted accelerated approval by the FDA for treatment of primary biliary cholangitis (PBC) in adults. It is indicated for use in combination with ursodeoxycholic acid (ursodiol, UDCA; Urso, and others) in patients with an inadequate response to UDCA alone and as monotherapy in those unable to tolerate UDCA.

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.

TThe FDA has licensed mResvia (Moderna), an mRNA respiratory syncytial virus (RSV) vaccine, for prevention of lower respiratory tract disease (LRTD) caused by RSV in adults ≥60 years old. It is the first mRNA vaccine to be licensed in the US for this indication. Two recombinant RSV vaccines, Arexvy and Abrysvo, are also available for prevention of RSV LRTD. Arexvy is approved for use in adults ≥50 years old. Abrysvo is approved for use in adults ≥60 years old and in pregnant women to prevent RSV LRTD in their infants.

Disruption of tear-film homeostasis (altered composition, reduced production, rapid evaporation) and resulting ocular surface inflammation cause the discomfort and blurred vision of dry eye disease. Many cases are caused by tear evaporation due to meibomian gland dysfunction. Other precipitating factors can include lacrimal gland dysfunction, poor eyelid function, environmental factors, extended screen time, inflammatory conditions such as Sjögren's syndrome, and use of some ocular or systemic drugs such as antihistamines, retinoids, or selective serotonin reuptake inhibitors...

Solifenacin succinate (VESIcare - Yamanouchi and GlaxoSmithKline) and darifenacin hydrobromide (Enablex - Novartis) have been approved by the FDA for oral treatment of overactive bladder.