The FDA has approved the oral tyrosine kinase inhibitor ripretinib (Qinlock – Deciphera) for treatment of adults with advanced gastrointestinal stromal tumors (GISTs) who have previously received treatment with ≥3 kinase inhibitors, including imatinib (Gleevec, and generics).

The oral second-generation antipsychotic drug lumateperone (Caplyta – Intra-Cellular Therapies), which was approved by the FDA in 2020 for treatment of schizophrenia, is now approved for use as monotherapy or as an adjunct to lithium or valproate for treatment of depressive episodes associated with bipolar I or II disorder in adults.

The FDA has approved Entadfi (Veru), a fixed-dose combination of the 5α-reductase inhibitor finasteride and the phosphodiesterase type 5 (PDE5) inhibitor tadalafil, for initial treatment of benign prostatic hyperplasia (BPH) in men with an enlarged prostate; use of the drug is limited to 26 weeks. Entadfi is the first 5α-reductase inhibitor/PDE5 inhibitor combination to become available in the US. Finasteride (Proscar, and generics) and tadalafil (Cialis, and generics) are also available separately.

Fezolinetant (Veozah – Astellas), a first-in-class neurokinin 3 (NK3) receptor antagonist, has been approved by the FDA for treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. It is the second nonhormonal treatment to be approved in the US for this indication; a low-dose formulation of the selective serotonin reuptake inhibitor (SSRI) paroxetine mesylate (Brisdelle) was approved in 2013.

The FDA has approved the interleukin (IL)-6 inhibitor sarilumab (Kevzara – Sanofi/Regeneron) for treatment of polymyalgia rheumatica (PMR) in adults who had an inadequate response to corticosteroids or cannot tolerate a corticosteroid taper. Sarilumab is the first biologic drug to be approved for treatment of PMR; it was previously approved for treatment of rheumatoid arthritis.

The FDA has approved daxibotulinumtoxinA-lanm (Daxxify – Revance), an acetylcholine release inhibitor and neuromuscular blocking agent, for temporary improvement in the appearance of moderate to severe glabellar (frown) lines associated with corrugator and/or procerus muscle activity. Daxxify is the fifth botulinumtoxin type A product to be approved in the US for this indication (see Table 1). It is also approved for treatment of cervical dystonia in adults

The FDA has approved Exblifep (Allecra), a fixed-dose combination of the cephalosporin cefepime and the beta-lactamase inhibitor enmetazobactam, for IV treatment of adults with complicated urinary tract infections (cUTIs), including pyelonephritis, caused by designated susceptible microorganisms (see Spectrum of Activity). Exblifep is the first product that contains enmetazobactam to be approved in the US.

Palopegteriparatide (Yorvipath – Ascendis), a parathyroid hormone (PTH) 1-34 analog, has been approved by the FDA for treatment of hypoparathyroidism in adults. The parathyroid hormone analog teriparatide (Forteo, and others), which is approved for treatment of postmenopausal osteoporosis, has been used off-label for treatment of hypoparathyroidism.

Onychomycosis is caused most commonly by Trichophyton rubrum or T. mentagrophytes. About 10% of all persons worldwide and 40% of those ≥60 years old are believed to have the disease. Risk factors include older age, diabetes, poor peripheral circulation, smoking, HIV infection, psoriasis, and immunosuppression. Left untreated, onychomycosis can cause nail plate destruction, ingrown nails, and (particularly in patients with diabetes) secondary infections. Guidelines on treatment of onychomycosis have been published.

Salmeterol xinafoate (Serevent - Allen & Hanburys), a long-acting β 2 -selective adrenergic agonist for inhalation, has been approved by the US Food and Drug Administration for maintenance treatment of asthma, with or without concurrent use of inhaled corticosteroids. Salmeterol is not recommended for acute treatment of bronchospasm.