The FDA has issued an Emergency Use Authorization (EUA) for a lower-strength (10 mcg/0.2 mL) formulation of the mRNA-based COVID-19 vaccine manufactured by Pfizer/BioNTech (Comirnaty) for use in children 5-11 years old. The original formulation of (Comirnaty) (30 mcg/0.3 mL) is FDA-licensed for use in persons ≥16 years old and available under an EUA for use in adolescents 12-15 years old.

The FDA has approved omidubicel-onlv (Omisirge – Gamida Cell), a nicotinamide-modified, allogeneic hematopoietic progenitor cell therapy derived from cord blood, to reduce the time to neutrophil recovery and the risk of infection in patients ≥12 years old with hematologic malignancies who will undergo umbilical cord blood transplantation following myeloablative conditioning therapy. Hematopoietic progenitor cell (HPC) umbilical cord products (e.g., Allocord, Clevecord, Ducord) have been available in the US for years for the same indication. Cord blood banks also supply cord...

Zanidatamab-hrii (Ziihera – Jazz), a bispecific HER2-directed antibody, has received accelerated approval from the FDA for treatment of unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer in patients who received prior therapy. Biliary tract cancer includes gallbladder cancer and intrahepatic and extrahepatic cholangiocarcinoma. Zanidatamab is the first dual HER2-targeted therapy to be approved in the US for this indication. Accelerated approval was based on the overall response rate and duration of response.

The Interruption of Anticoagulation section of our article on Treatment of Atrial Fibrillation cited the recommendations of the American College of Chest Physicians on perioperative management of antithrombotic therapy (JD Douketis et al. Chest 2022; 162:e207). A reader suggested that our general statement on when to discontinue an oral anticoagulant would have benefited from inclusion of the recommendations of the American College of Cardiology/American Heart Association (JA Joglar et al. Circulation 2024; 149:e1). Recommendations for periprocedural management of oral anticoagulant therapy...

The US Food and Drug Administration (FDA) recently approved HibTITER (Lederle-Praxis) and PedvaxHIB (Merck), two new Haemophilus influenzae type b conjugate vaccines, for use in infants as part of their primary immunization schedule.

Summer heat waves cause thousands of cases of heat-related illness in the US each year and hundreds of heat-related deaths, especially among the elderly. This review describes the contributing factors, clinical signs, and ways to prevent and treat heat injury.

The FDA has licensed PreHevbrio (VBI Vaccines), a recombinant, 3-antigen, 3-dose hepatitis B vaccine, for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults. It has been available in Israel since 2000.

A randomized, placebo-controlled, double-blind trial of exemestane (Aromasin, and others) in postmenopausal women considered at increased risk for breast cancer found that the aromatase inhibitor, over a median follow-up of 35 months, significantly decreased the annual incidence of invasive breast cancer from 0.55% to 0.19% (PE Goss et al. N Engl J Med, epub June 4, 2011).

Citing some recent reports, the FDA has announced changes in the safety labeling of all HMG-CoA reductase inhibitors (statins).

Persons planning to travel outside the US should be up to date on routine vaccines and, depending on their destination, duration of travel, and planned activities, may also receive certain travel-specific vaccines. Tickborne encephalitis and dengue vaccines, which are not available in the US, are reviewed in a separate article available online. Detailed advice for travel to specific destinations is available from the Centers for Disease Control and Prevention (CDC) at www.cdc.gov/travel/destinations/list. Recommendations for administration of vaccines as part of routine...