In June 2021, the FDA approved the IV amyloid beta-directed monoclonal antibody aducanumab (Aduhelm) for treatment of Alzheimer’s disease. The approval did not restrict use of the drug to patients with mild cognitive impairment or mild dementia, which was the population enrolled in the clinical trials. Now, Biogen, with the permission of the FDA, has made an addition to the labeling of the drug that says: Treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical...

The Centers for Disease Control and Prevention (CDC) and the Environmental Protection Agency (EPA) recommend using insect repellents to prevent infections transmitted by mosquitoes and ticks. Insect repellents applied to exposed skin should be used in conjunction with other preventive measures such as wearing pants and long-sleeved shirts and avoiding outdoor activities during peak mosquito-biting times. Mosquitoes can transmit diseasecausing pathogens, including Zika, chikungunya, dengue, West Nile, eastern equine encephalitis, and yellow fever viruses, and the malaria parasite....

The oral sphingosine 1-phosphate (S1P) receptor modulator ozanimod (Zeposia – Bristol Myers Squibb) has been approved by the FDA for treatment of adults with moderately to severely active ulcerative colitis. It is the first S1P receptor modulator to be approved for treatment of ulcerative colitis. Ozanimod was approved in March 2020 for use in adults with relapsing forms of multiple sclerosis.

The injectable interleukin (IL)-23 antagonist mirikizumab-mrkz (Omvoh – Lilly) is now FDA-approved for treatment of moderately to severely active Crohn's disease (CD) in adults. Mirikizumab was approved in 2023 for treatment of ulcerative colitis. Two other IL-23 antagonists, risankizumab (Skyrizi) and guselkumab (Tremfya), are also approved for treatment of CD.

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.

The FDA has approved an IV formulation of the antifungal drug posaconazole (Noxafil - Merck) for prophylaxis of Aspergillus and Candida infections in adults at high risk for these infections, such as those with prolonged neutropenia. Posaconazole is also available as delayed-release tablets and an oral suspension.With activity against Aspergillus and Candida, posaconazole has an antifungal spectrum similar to that of voriconazole (Vfend, and generics), but unlike voriconazole it is also active against many species of Mucorales (formerly called Zygomycetes), such as Mucor and Rhizopus....

In our article on Slynd (Med Lett Drugs Ther 2020; 62:18), the drospirenone-only oral contraceptive, we mentioned that drospirenone has antiandrogenic activity that could improve acne and antimineralocorticoid activity that could cause hyperkalemia. We should have added that concurrent use of drospirenone with other drugs that increase potassium levels, such as the anti-androgen aldosterone receptor antagonist spironolactone (Aldactone, and generics), which is often used off-label for treatment of acne, can increase the risk of hyperkalemia.

Mupirocin (Bactroban - Beecham), a topical antibiotic formerly called pseudomonic acid, was recently approved by the US Food and Drug Administration for treatment of impetigo. It will be sold as a 2% ointment available only by prescription.

The FDA has approved valbenazine (Ingrezza – Neurocrine Biosciences), a vesicular monoamine transporter 2 (VMAT2) inhibitor, for treatment of tardive dyskinesia in adults. It is the first drug to be approved in the US for this indication; two other VMAT2 inhibitors, tetrabenazine (Xenazine, and generics) and deutetrabenazine (Austedo), were approved earlier for treatment of chorea associated with Huntington's disease.

The FDA has approved Biktarvy (Gilead), a once-daily, fixed-dose combination of bictegravir, a new integrase strand transfer inhibitor (INSTI), and the nucleoside reverse transcriptase inhibitors (NRTIs) emtricitabine and tenofovir alafenamide (TAF), for treatment of HIV-1 infection in adults. The new combination is indicated for use in patients who are antiretroviral-naive or who have been virologically suppressed on a stable antiretroviral regimen for ≥3 months with no history of treatment failure and no known substitutions associated with resistance to any component of the...