The potassium-competitive acid blocker vonoprazan (Voquezna – Phathom), which was approved earlier for treatment of erosive esophagitis, has now been approved by the FDA for relief of heartburn associated with nonerosive gastroesophageal reflux disease (GERD) in adults. Vonoprazan is also available copackaged with amoxicillin (Voquezna Dual Pak) and with amoxicillin and clarithromycin (Voquezna Triple Pak) for treatment of Helicobacter pylori infection.

The FDA has approved ensitrelvir (Xocova – Shionogi), a SARS-CoV-2 main protease inhibitor, for postexposure prophylaxis of COVID-19 in patients ≥12 years old who had contact with an infected individual. Ensitrelvir is the first oral antiviral drug to be approved in the US for this indication. The parenteral monoclonal antibody combinations bamlanivimab and etesevimab and casirivimab and imdevimab (REGEN-COV) are no longer authorized for postexposure prophylaxis of COVID-19 in the US.

Caspofungin acetate(Cancidas) is the first of a new class of antifungals, the echinocandins. It has been approved by the FDA for treatment of invasive aspergillosis in patients who fail to respond to or are unable to tolerate other antifungal drugs such as amphotericin B and itraconazole.

Ziftomenib (Komzifti – Kura), an oral menin inhibitor, has been approved by the FDA for treatment of adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options. It is the second oral menin inhibitor to be approved in the US for this indication; revumenib (Revuforj) was approved in October 2025 for use in patients ≥1 year old.

The FDA has approved Zunveyl (Alpha Cognition), a delayed-release formulation of the prodrug benzgalantamine, for treatment of mild to moderate dementia of Alzheimer's disease (AD). Immediate- and extended-release formulations of the acetylcholinesterase inhibitor galantamine have been available in the US for years for treatment of AD.

The FDA has approved Onyda XR (Tris), an extended-release (ER) oral suspension formulation of the alpha_2-adrenergic agonist clonidine, for use as monotherapy or as an adjunct to stimulant therapy for treatment of attention-deficit/hyperactivity disorder (ADHD) in children ≥6 years old. Clonidine ER tablets have been available for years for treatment of ADHD in children 6-17 years old.

Cetirizine (Zyrtec, and others) and cetirizine/pseudoephedrine (Zyrtec-D) are becoming available without a prescription this month for treatment of allergic rhinitis and urticaria in adults and children. Cetirizine is the second of the second-generation H1-antihistamines to become available over the counter. Loratadine (Claritin, and others) was the first.Cetirizine has been shown to be more effective than loratadine in suppressing histamine-induced wheals in healthy volunteers (W Carey et al. Drugs Exp Clin Res 2002; 28:243), but no well-controlled clinical trials have established that any...

The FDA recently advised health care professionals and consumers not to use a number of dietary supplements found to contain the phosphodiesterase-5 inhibitor sildenafil (Viagra) or an analog of the drug (www.fda.gov). Although the effects of sildenafil may be noticeable (in men), the presence of other, possibly more toxic adulterants in dietary supplements may be more difficult or impossible to detect.Other drugs previously found in dietary supplements have included lovastatin (Mevacor, and others), estrogen, alprazolam (Xanax, and others), indomethacin (Indocin, and others) and warfarin...

The Medical Letter was founded in 1959 by Arthur Kallet, an engineer, and Dr. Harold Aaron, an internist. In 1932, Kallet had written the book 100,000,000 Guinea Pigs, a best-seller that was partly responsible for the Food and Drug Act of 1938, which required for the first time that new drugs show proof of safety. He was the founding director of Consumers Union and started the publication of Consumer Reports. Dr. Aaron, who became the medical director of Consumer Reports, suggested to Kallet that doctors could use a similar publication to evaluate the new drugs that were coming on the market...

The FDA has approved ruxolitinib (Jakafi – Incyte), a janus-associated kinase (JAK) inhibitor, for treatment of myelofibrosis. Jakafi is the first JAK inhibitor to be approved for any indication and the only drug approved for treatment of myelofibrosis.