The FDA has approved three office laboratory tests for diagnosis of influenza. These tests are of special interest now because the FDA recently also approved two new drugs for treatment of influenza that must be started--to be effective--less than 48 hours after the onset of symptoms.

The results of a clinical trial (PRECISION) comparing the cardiovascular safety of the COX-2 selective NSAID celecoxib (Celebrex, and generics) with that of ibuprofen and naproxen, which are nonselective, have been described in the lay press in terms that may overestimate the safety of celecoxib.

The FDA has approved an over-the-counter (OTC) 0.025% ophthalmic formulation of the selective alpha₂-adrenergic agonist brimonidine tartrate (Lumify – Bausch & Lomb) for treatment of ocular redness in adults and children ≥5 years old. Lumify is the first brimonidine product to be approved for OTC use.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga – AstraZeneca) has been approved by the FDA for treatment of adults with chronic kidney disease (CKD) at risk of progression (not defined in the label). Dapagliflozin is the first SGLT2 inhibitor to be approved in the US for treatment of CKD.

Excessive exposure to ultraviolet (UV) radiation is associated with sunburn, photoaging, and skin cancer. Sunscreens are widely used to reduce these risks, but questions remain about their effectiveness and safety. The FDA has issued a proposed rule that would require manufacturers to perform additional safety studies for some sunscreen active ingredients and would mandate better UVA protection in sunscreen products. Some sunscreen products containing FDA-approved active ingredients are listed in Table 2.

Exagamglogene autotemcel (Casgevy – Vertex), a cell-based gene therapy recently approved for treatment of sickle cell disease1, has now been approved by the FDA for treatment of patients ≥12 years old with transfusion-dependent beta thalassemia. Casgevy is the first gene therapy that uses CRISPR/Cas9 gene-editing technology to be approved in the US for any disorder. Betibeglogene autotemcel (Zynteglo), an autologous lentiviral vector cell-based gene therapy, was approved in the US in 2022 for treatment of transfusion-dependent beta thalassemia.

Rasagiline (Azilect - Teva), a monoamine oxidase-type B (MAO-B) inhibitor, was recently approved by the FDA for once-daily oral treatment of Parkinson's disease (PD). It can be taken alone for treatment of early disease or with levodopa/carbidopa (Sinemet, and others) for advanced disease. Selegiline (Eldepryl, and others), the first MAO-B inhibitor marketed in the US, has been available since 1988; a new lower-dose disintegrating tablet (Zelapar) was recently approved.

Levocetirizine (Xyzal - UCB/Sanofi-aventis), the active enantiomer of the second-generation H₁-antihistamine cetirizine (Zyrtec), has been approved by the FDA for treatment of seasonal and perennial allergic rhinitis (SAR and PAR) and chronic idiopathic urticaria in adults and children 6 years of age and older. Cetirizine has been approved by the FDA for over-the-counter use and may also become available generically in the US. Levocetirizine has been available in Europe since 2001.

Photopheresis is a new technique recently approved by the US Food and Drug Administration for treatment of cutaneous T-cell lymphoma. It combines oral administration of a photoactivatable cytotoxic drug with leukapheresis and extracorporeal exposure of leukocytes to long-wave ultraviolet light (UVA). This procedure requires use of a 'UVAR Instrument' manufactured by Therakos, a subdivision of Johnson and Johnson.

To avoid the morbidity and occasional mortality of transurethral resection or open prostatectomy, some urologists are now using balloon dilatation of the prostatic urethra to treat benign prostatic hypertrophy.