Qbrexza (Dermira), a premoistened cloth containing the long-acting anticholinergic drug glycopyrronium, has been approved by the FDA for once-daily topical treatment of excessive underarm sweating (primary axillary hyperhidrosis) in patients ≥9 years old. Glycopyrronium bromide (glycopyrrolate) has been available for years in parenteral, inhalation, and oral formulations for treatment of multiple conditions.

The oral kinase inhibitor pemigatinib (Pemazyre – Incyte) has received accelerated approval from the FDA for treatment of adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with fibroblast growth factor receptor 2 (FGFR2) fusions or other rearrangements. Pemigatinib is the first drug to be approved in the US for this indication.

Teprotumumab-trbw (Tepezza - Horizon), an insulin-like growth factor-1 receptor (IGF-1R) inhibitor, has been approved by the FDA for IV treatment of thyroid eye disease. It is the first drug to be approved in the US for this indication.

Tyrvaya (Oyster Point), a nasal spray formulation of the cholinergic agonist varenicline, has been approved by the FDA for treatment of dry eye disease. It is the first nasal spray to be approved in the US for this indication. An oral formulation of varenicline (Chantix, and generics) has been available for years for smoking cessation.

The FDA has approved Tarpeyo (Calliditas), a delayed-release capsule formulation of the corticosteroid budesonide, to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN; also called Berger's disease) who are at risk of rapid disease progression. It is the fi rst drug to be approved in the US for this indication. Oral formulations of budesonide have been available for years for treatment of inflammatory bowel disease.

Amivantamab-vmjw (Rybrevant – Janssen), an EGFR-MET bispecific antibody, has received accelerated approval from the FDA for IV treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations in adults whose disease has progressed on or after platinum-based chemotherapy. It is the first bispecific antibody to become available in the US for this indication. Accelerated approval of the drug was based on the overall response rate and duration of response.

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 Xacduro (Innoviva), a combination of the beta-lactam antibacterial sulbactam and the beta-lactamase inhibitor durlobactam, for IV treatment of adults with hospital-acquired or ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (ABC).

The FDA has approved cantharidin 0.7% solution (Ycanth – Verrica) for topical treatment of molluscum contagiosum in patients ≥2 years old. Ycanth was the first drug to be approved in the US for this indication. A 10.3% gel formulation of berdazimer (Zelsuvmi), a nitric oxide-releasing agent, has also been approved by the FDA for treatment of molluscum contagiosum (in patients ≥1 year old); it will be reviewed in a future issue.

Berdazimer 10.3% gel (Zelsuvmi – Ligand), a first-in-class nitric oxide-releasing agent, has been approved by the FDA for topical treatment of molluscum contagiosum in patients ≥1 year old. It is the second drug to become available in the US for treatment of molluscum contagiosum and the first that can be applied by the patient or caregiver at home; cantharidin 0.7% solution (Ycanth), which is applied by a healthcare professional, was approved earlier for use in patients ≥2 years old.