On April 13, 2021, the FDA and CDC advised suspending use of the Johnson & Johnson adenovirus-based COVID-19 vaccine while the agencies investigate 6 cases of cerebral venous sinus thrombosis (CVST) and thrombocytopenia that occurred following administration of the vaccine. In an April 14 emergency meeting, the Advisory Committee on Immunization Practices (ACIP) recommended continuing the suspension until more data become available. About 7 million people in the US have received the Johnson & Johnson vaccine.

The FDA has expanded its Emergency Use Authorizations (EUAs) for the COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to permit use of the bivalent formulations of these products (containing mRNA from the original and BA.4/5 Omicron strains of SARS-CoV-2) as a booster dose in children as young as 5 years old (Pfizer) or 6 years old (Moderna). The bivalent Pfizer vaccine had previously been authorized for use in persons ≥12 years old and the bivalent Moderna vaccine in persons ≥18 years old. Bivalent vaccines are not authorized for...

Lasers have been used in dermatology for many years. Recently, however, improvements in laser technology have led to much wider use of lasers for treatment of cosmetic skin problems. Many different types of lasers are available; the US Food and Drug Administration gives manufacturers permission to market laser systems for specific indications.

The FDA has approved emicizumab-kxwh (Hemlibra – Genentech), a subcutaneously injected, factor IXa- and X-directed antibody, for routine prophylaxis to prevent or reduce bleeding episodes in patients with hemophilia A. Emicizumab is not recommended for treatment of bleeding.

Ferric carboxymaltose (Injectafer – American Regent) is now FDA-approved for IV treatment of iron deficiency in adults with New York Heart Association (NYHA) class II/III heart failure to improve exercise capacity. Iron deficiency is present in approximately 30% of patients with heart failure; it has been associated with reduced quality of life and increased hospitalization and mortality. Injectafer is the first IV iron preparation to be approved for this indication. It was previously approved for treatment of iron deficiency anemia in children and adults.

Use of screening tests to identify cancers before they cause symptoms can lead to earlier therapy and may improve outcomes. Screening tests for some common cancers are reviewed below.

The recent terrorist attacks on the US have led to many questions about the clinical effects, prevention and treatment of injury caused by chemical warfare agents.

The FDA has approved the marketing of RotaShield, a live oral vaccine for prevention of infantile rotavirus infection. Rotaviruses are segmented double-stranded RNA viruses that are the most common cause of severe diarrhea and dehydration in infants and young children.

In the absence of randomized studies demonstrating an impact on mortality, the US Preventive Services Task Force (USPSTF) has found the evidence insufficient to recommend a routine whole-body examination for melanoma and other skin cancers.

The FDA has approved florbetapir F18 (flor bay´ ta pir; Amyvid – Lilly), an intravenous radioactive diagnostic agent used with positron emission tomography (PET) scans, to estimate β-amyloid neuritic plaque density in adults being evaluated for Alzheimer's disease (AD) or other causes of cognitive decline.