The investigational neutralizing IgG1 monoclonal antibody bamlanivimab (LY-CoV555; Lilly) has been granted an FDA Emergency Use Authorization (EUA) for treatment of recently diagnosed mild to moderate COVID-19 in patients who are ≥12 years old, weigh at least 40 kg, and are at high risk for progressing to severe disease and/or hospitalization (see Table 1).

The FDA has approved Dextenza (Ocular Therapeutix), a dexamethasone ophthalmic insert, for treatment of ocular itching associated with allergic conjunctivitis. Dextenza was approved earlier for treatment of ocular inflammation and pain following ophthalmic surgery.

The FDA has approved acoramidis (Attruby – BridgeBio), an oral transthyretin stabilizer, to reduce cardiovascular-related hospitalization and cardiovascular death in adults with wild-type or variant (hereditary) transthyretin amyloid cardiomyopathy (ATTR-CM). Acoramidis is the second transthyretin stabilizer to be approved in the US for this indication; tafamidis (Vyndaqel, Vyndamax) was approved in 2019.

The FDA has approved Apretude (ViiV Healthcare), an IM extended-release (ER) formulation of the integrase strand transfer inhibitor (INSTI) cabotegravir, for use every 2 months to prevent sexually acquired HIV-1 infection in at-risk adolescents and adults. Apretude is the first ER formulation to be FDA-approved for pre-exposure prophylaxis (PrEP) of HIV-1 infection.

The FDA has approved sotagliflozin (Inpefa – Lexicon), an oral sodium-glucose cotransporter 1 and 2 (SGLT1/2) inhibitor, to reduce the risk of hospitalization for heart failure (HF), urgent HF visits, and cardiovascular death in adults with either HF (with any left ventricular ejection fraction [LVEF]) or type 2 diabetes, chronic kidney disease (CKD), and other cardiovascular risk factors. Sotagliflozin is the first dual SGLT1/2 inhibitor to be approved in the US. Unlike SGLT2 inhibitors, it is not FDA-approved to improve glycemic control in adults with type 2 diabetes....

Cognitive behavioral therapy for insomnia (CBT-I) is recommended for initial treatment of chronic insomnia. CBT-I includes stimulus control, sleep education and hygiene, sleep restriction, relaxation training, and cognitive therapy. When CBT-I alone is not effective, pharmacologic treatment should be added.

The FDA has required a new warning in the labels of prescription and over-the-counter products containing nonsteroidal anti-inflammatory drugs (NSAIDs) advising against their use during pregnancy beginning at 20 weeks’ gestation because of a risk of renal dysfunction in the fetus that could lead to low amniotic fluid levels (oligohydramnios) and neonatal renal impairment. NSAID labels previously warned against use of the drugs beginning at 30 weeks' gestation because of a risk for premature closure of the ductus arteriosus and persistent neonatal pulmonary hypertension

The FDA has issued an Emergency Use Authorization (EUA) for the long-acting investigational IV monoclonal antibody pemivibart (Pemgarda – Invivyd) for pre-exposure prophylaxis of COVID-19 in persons ≥12 years old (weight ≥40 kg) who have moderate to severe immune compromise and are unlikely to respond adequately to COVID-19 vaccination (see Table 1). Pemgarda is the only drug that is currently authorized in the US for pre-exposure prophylaxis of COVID-19. Tixagevimab/cilgavimab (Evusheld) was previously available under an EUA for this indication, but it lacks activity against...

The FDA has approved Erzofri (Luye), an extended-release injectable formulation of the second-generation antipsychotic drug paliperidone palmitate, for treatment of schizophrenia and schizoaffective disorder in adults. It is the second once-monthly formulation of paliperidone palmitate to be approved in the US for these indications; Invega Sustenna was the first. Longer-acting injectable formulations of paliperidone palmitate are also available (see Table 1).

The FDA has approved changes to the labeling of Sublocade (Indivior), an extended-release formulation of the partial opioid agonist buprenorphine, to permit faster initiation and use of alternative injection sites. Sublocade is indicated for once-monthly subcutaneous treatment of moderate to severe opioid use disorder.