On February 27, 2021, the FDA issued an Emergency Use Authorization (EUA) for the Johnson & Johnson adenovirus-based vaccine for prevention of COVID-19 in persons ≥18 years old. It is the third COVID-19 vaccine to become available in the US and the first to require only a single dose. Two-dose mRNA-based vaccines manufactured by Pfizer-BioNTech and Moderna received EUAs in December 2020.

In February 2021, the FDA issued an Emergency Use Authorization (EUA) for the investigational monoclonal antibodies bamlanivimab and etesevimab (Lilly) for use together to treat mild to moderate COVID-19 in persons ≥12 years old who weigh ≥40 kg and are at high risk of progression to severe disease or hospitalization. The FDA has now expanded this EUA to allow use of the antibodies together for post-exposure prophylaxis of COVID-19 in such persons if they are not fully vaccinated against COVID-19 or are unlikely to have an adequate immune response to full vaccination and have...

Miudella (Sebela), a copper intrauterine device (IUD), has been approved by the FDA for prevention of pregnancy for up to 3 years. Miudella is the second copper IUD to be approved in the US; ParaGard, which contains more copper and is approved for up to 10 years of use, was approved in 1984. Four hormonal IUDs (Mirena, Liletta, Skyla, Kyleena) that release the progestin levonorgestrel are also available for pregnancy prevention (see Table 2).

Now that US Secretary of Defense has decided to vaccinate more than 2 million memebers of the US armed forces against anthrax, US physicians may be asked to answer some questions about the vaccine and the disease.

The FDA has approved the marketing of Natazia (Bayer), a 4-phase oral contraceptive containing the estrogen estradiol valerate and the progestin dienogest, both used for the first time in the US for this indication.

The US Advisory Committee on Immunization Practices (ACIP) has recommended that adults with immunocompromising conditions receive the 13-valent pneumococcal conjugate vaccine (PCV13; Prevnar 13), even if they have already received the older 23-valent unconjugated vaccine (PPSV23; Pneumovax 23). Prevnar 13, initially approved by the FDA for use in infants and young children, has been licensed since December 2011 for adults ≥50 years old.

Electronic cigarettes, also called e-cigarettes, are advertised as a safer, more convenient, and socially acceptable alternative to smoking tobacco cigarettes. Widely available in retail stores and on the Internet, their use has been increasing over recent years, primarily among smokers, but also among non-smokers.

The FDA has approved Yosprala (Aralez), a fixed-dose combination of delayed-release aspirin and immediate-release omeprazole, for secondary prevention of cardiovascular and cerebrovascular events in patients who are at risk of developing aspirin-associated gastric ulcers (≥55 years old or history of gastric ulcers). Yosprala is the first product to become available in the US that combines aspirin and a proton pump inhibitor (PPI).

The FDA has expanded its Emergency Use Authorization for the adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax to include its use as a first booster dose in adults who completed a primary series with any COVID-19 vaccine ≥6 months previously and are unable or unwilling to receive a booster dose of a bivalent mRNA vaccine. The Novavax vaccine is not authorized for use in persons who have received a booster dose of any other COVID-19 vaccine.

Remestemcel-L (Ryoncil – Mesoblast), an allogeneic bone marrow-derived mesenchymal stromal cell therapy, has been approved by the FDA for treatment of steroid-refractory acute graft-versus-host disease (GVHD) in patients ≥2 months old. Steroid-refractory GVHD is associated with a poor prognosis, organ damage, and death, particularly in pediatric patients. Remestemcel-L is the first cellular therapy to be approved in the US for this indication and the only treatment of any kind to be approved for GVHD in children <12 years old.