The FDA has now approved a recombinant, 9-valent, human papillomavirus (HPV) vaccine (Gardasil 9 – Merck) for use in girls and women 9-26 years old and boys 9-15 years old. The new vaccine is indicated to prevent diseases associated with infection with HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, which include genital warts and cervical, vulvar, vaginal, and anal precancerous lesions and cancer. Two recombinant HPV vaccines are already available in the US: Gardasil prevents disease associated with HPV types 6, 11, 16, and 18, and Cervarix prevents disease associated with HPV...

The FDA has approved Incruse Ellipta (GSK), a single-agent inhaler containing the long-acting anticholinergic umeclidinium, for once-daily maintenance treatment of chronic obstructive pulmonary disease (COPD). Umeclidinium was initially approved in combination with the long-acting beta₂-adrenergic agonist vilanterol as Anoro Ellipta.

The FDA has approved AspireAssist (Aspire Bariatrics), a weight-loss device that permits patients to drain a portion of their stomach contents through a gastrostomy tube into a toilet after each meal. It is approved for long-term use in combination with lifestyle modifications in adults ≥22 years old who have a body mass index (BMI) of 35 to 55 and have not been able to achieve and maintain weight loss with nonsurgical therapy.

The FDA has approved a manually injected, single-dose, prefilled epinephrine syringe (Symjepi – Adamis/Sandoz) for emergency treatment of anaphylaxis. The new device is approved in 0.3- and 0.15-mg strengths for treatment of patients weighing ≥30 kg and 15 to 30 kg, respectively; only the 0.3-mg strength is currently available. According to Sandoz, Symjepi will be made available first to institutions and later to the retail market.

The FDA has approved a higher-dose intranasal naloxone formulation (Kloxxado – Hikma) for emergency treatment of opioid overdose. A single spray of the new formulation delivers 8 mg of naloxone; a formulation that delivers 4 mg per spray (Narcan) was approved in 2015.

Tezepelumab-ekko (Tezspire – AstraZeneca/Amgen), a subcutaneously administered thymic stromal lymphopoietin (TSLP) blocker, has been approved by the FDA for add-on maintenance treatment of severe asthma in patients ≥12 years old. It is the first TSLP blocker to become available in the US and the first biologic drug to be approved for treatment of severe asthma without phenotypic or biomarker limitations.

The FDA has issued an Emergency Use Authorization (EUA) for an adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax. The vaccine is indicated for use as a two-dose primary series to prevent COVID-19 in adults; it is not authorized for use in children or as a booster dose. Three other COVID-19 vaccines are available in the US for primary immunization of adults; the mRNA vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) are FDA-licensed for this indication, and the adenovirus-based vaccine manufactured by Johnson & Johnson (Janssen) is...

The FDA has approved tislelizumab (Tevimbra – BeiGene), a programmed death receptor-1 (PD-1) blocking antibody, for treatment of unresectable or metastatic esophageal squamous cell cancer in adults who received prior systemic chemotherapy that did not include a programmed death ligand-1 (PD-L1) inhibitor.

Brella Sweat Control Patch (Candesant Biomedical), a sodium-containing transdermal patch, has been cleared by the FDA for in-office treatment of primary axillary hyperhidrosis in adults. It is the first patch to be approved in the US for this indication.

The FDA has approved a 0.15% cream formulation of the phosphodiesterase-4 (PDE4) inhibitor roflumilast (Zoryve – Arcutis) for topical treatment of mild to moderate atopic dermatitis (AD) in patients ≥6 years old. Roflumilast is the second PDE4 inhibitor to be approved in the US for treatment of AD; crisaborole (Eucrisa), which can be used in patients ≥3 months old, was the first. Roflumilast is available as Zoryve in a 0.3% cream for treatment of plaque psoriasis and a 0.3% foam for treatment of seborrheic dermatitis. It is also available in an oral formulation (Daliresp) for...