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...

The FDA has approved the use of an equine heptavalent botulism antitoxin (BAT, Cangene Corporation). The new antitoxin includes antibodies against all 7 botulinum neurotoxin types (A-G). A human-derived antitoxin (BabyBIG) has been available for years for infant botulism. The heptavalent product is now the preferred antitoxin for adult botulism. It is a solution of immunoglobulin fragments obtained from equine plasma that has gone through several steps of purification and viral inactivation. (The use of immunoglobulin fragments reduces side effects compared to intact...

On August 6, 2019, the FDA issued a statement on data manipulation/inaccuracy issues with Zolgensma, a virus vector-based gene therapy approved for one-time IV treatment of children <2 years old with spinal muscular atrophy.1 We reviewed Zolgensma in our July 29 issue.2 According to the FDA statement, the manipulated data pertained to the production process for the product and did not affect the efficacy or safety results from the human clinical trials. It does not require any change in our review.FDA Statement. Statement on data accuracy issues with recently approved gene therapy....