The FDA has approved gepotidacin (Blujepa – GSK), a triazaacenaphthylene bacterial type II topoisomerase inhibitor, for oral treatment of uncomplicated urinary tract infections (uUTI) in female patients ≥12 years old who weigh ≥40 kg. Gepotidacin is the first triazaacenaphthylene antibiotic to be approved in the US.

The Centers for Disease Control and Prevention (CDC) and the Environmental Protection Agency (EPA) recommend using insect repellents to avoid being bitten by mosquitoes, ticks, and other arthropods that transmit disease-causing pathogens. Repellents applied to exposed skin should be used in conjunction with other preventive measures such as wearing long-sleeved shirts, pants, and socks and avoiding outdoor activities during peak mosquito-biting times. Some insect repellents are listed in Table 1.

Maribavir (Livtencity – Takeda), an oral cytomegalovirus (CMV) pUL97 kinase inhibitor, has been approved by the FDA for treatment of post-transplant CMV infection refractory to standard antiviral therapy in patients ≥12 years old who weigh at least 35 kg.

Mobocertinib (Exkivity – Takeda), an oral kinase inhibitor, has received accelerated approval from the FDA for treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations in adults whose disease has progressed on or after platinum-based chemotherapy. Accelerated approval was based on the overall response rate and duration of response. Mobocertinib is the second drug to become available in the US for this indication; the IV EGFR-MET bispecific antibody amivantamab (Rybrevant) was approved...

AD-Detect (Quest), a blood test to evaluate Alzheimer's disease risk, is being marketed directly to consumers. It has not been cleared or approved by the FDA (laboratory-developed tests like this one currently do not need FDA authorization to be marketed).

The FDA has required that the labels of all carbidopa/levodopa-containing products (Crexont, Dhivy, Duopa, Rytary, Sinemet, Sinemet CR, Stalevo, Vyalev) include a warning about the risk of vitamin B6 (pyridoxine) deficiency and vitamin B6 deficiency-related seizures associated with their use. The combination of carbidopa/levodopa is the most effective treatment for the motor symptoms of Parkinson's disease and recent evidence favors its early use.

The FDA has amended its Emergency Use Authorization (EUA) for Paxlovid (Pfizer), the investigational oral antiviral drug nirmatrelvir copackaged with oral ritonavir, to allow for it to be prescribed by licensed pharmacists in certain situations. Paxlovid is authorized for oral treatment of mild to moderate COVID-19 in high-risk outpatients ≥12 years old who weigh at least 40 kg. NIH guidelines list it as the treatment of choice for COVID-19 in high-risk adult outpatients.

The FDA has authorized use of the Visby Medical Women's Sexual Health Test (Visby), an at-home test available without a prescription, for detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis infections in women with and without symptoms. It is the first test to become available in the US for these sexually transmitted infections (STIs) that can be performed entirely at home. Other at-home tests are available in the US for diagnosis of chlamydia, gonorrhea, and trichomoniaisis, but they require mailing a urine or blood sample to a...

Vimseltinib (Romvimza – Deciphera), an oral kinase inhibitor, has been approved by the FDA for treatment of symptomatic tenosynovial giant cell tumor in adults for whom surgical resection would cause worsening functional limitation or severe morbidity. The kinase inhibitor pexidartinib (Turalio) was approved for a similar indication in 2019.

The FDA has licensed mNEXSPIKE (Moderna), an mRNA vaccine, for prevention of COVID-19 in adults ≥65 years old and in persons 12-64 years old who have a condition that puts them at high risk for severe outcomes from COVID-19. Spikevax, the original Moderna mRNA COVID-19 vaccine, remains in production2; it is licensed for use in persons ≥12 years old and is available under an Emergency Use Authorization (EUA) for children 6 months to 11 years old.