The FDA has expanded its Emergency Use Authorizations (EUAs) for the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to allow for their use in children as young as 6 months old. The Pfizer vaccine was previously authorized for use in persons ≥5 years old, and the Moderna vaccine was authorized for use in adults ≥18 years old.

The FDA has approved the subcutaneously injected interleukin (IL)-4 receptor alpha antagonist dupilumab (Dupixent – Sanofi/Regeneron) for treatment of eosinophilic esophagitis (EoE) in patients ≥12 years old who weigh ≥40 kg and treatment of prurigo nodularis in adults. Dupilumab is the first drug to be approved in the US for each of these indications. It is also FDA-approved for treatment of atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis.

Primary hypothyroidism is usually the result of Hashimoto's (autoimmune) thyroiditis, thyroidectomy, or radioactive iodine therapy. Treatment of hypothyroidism with replacement doses of thyroid hormone is usually lifelong. Levothyroxine (LT4; synthetic thyroxine; Synthroid, and others) is the drug of choice.1

The FDA has approved Phexxi (Evofem), a nonhormonal prescription-only vaginal gel containing lactic acid, citric acid, and potassium bitartrate, for prevention of pregnancy. The gel is intended for on-demand contraception; it is not effective when used after intercourse. It was previously approved for use as a vaginal lubricant (Amphora), but was never marketed.

Mosunetuzumab-axgb (Lunsumio – Genentech), a bispecific CD20-directed CD3 T-cell engager, has received accelerated approval from the FDA for treatment of relapsed or refractory follicular lymphoma in adults who received ≥2 lines of systemic therapy. It is the first T-cell-engaging bispecific antibody to be approved in the US for this indication.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga – AstraZeneca) has been approved by the FDA for treatment of adults with chronic kidney disease (CKD) at risk of progression (not defined in the label). Dapagliflozin is the first SGLT2 inhibitor to be approved in the US for treatment of CKD.

Excessive exposure to ultraviolet (UV) radiation is associated with sunburn, photoaging, and skin cancer. Sunscreens are widely used to reduce these risks, but questions remain about their effectiveness and safety. The FDA has issued a proposed rule that would require manufacturers to perform additional safety studies for some sunscreen active ingredients and would mandate better UVA protection in sunscreen products. Some sunscreen products containing FDA-approved active ingredients are listed in Table 2.

View the Expanded Table: Some Oral Drugs for Chronic Insomnia

The investigational monoclonal antibodies casirivimab and imdevimab (REGEN-COV – Regeneron) have been available in the US under an Emergency Use Authorization (EUA) since late 2020 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...

Atrial fibrillation (AF) is the most common arrhythmia in the world. Risk factor modification, anticoagulation, rhythm control, and rate control are the four pillars of its management. American College of Cardiology/American Heart Association (ACC/AHA) guidelines on management of AF were updated recently.