The FDA has approved Inlexzo, a gemcitabine intravesical system, for treatment of Bacillus Calmette-Guérin (BCG)-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors. The Inlexzo system is placed into the bladder to deliver gemcitabine for 3 weeks.

Nerandomilast (Jascayd – Boehringer Ingelheim), an oral phosphodiesterase 4 (PDE4) inhibitor, has been approved by the FDA for treatment of idiopathic pulmonary fibrosis (IPF) in adults. It is the third drug to be approved in the US for this indication; the oral antifibrotic drugs pirfenidone (Esbriet, and generics) and nintedanib (Ofev) were approved in 2014.

Lyme disease in the US is caused by the spirochete Borrelia burgdorferi, which is transmitted to humans by Ixodes scapularis (blacklegged [deer] tick) and I. pacificus (western blacklegged tick). Most cases of Lyme disease occur in late spring and early summer in northeastern and mid-Atlantic states, the upper Midwest, and in northern California. B. mayonii, which is also transmitted by I. scapularis, has been shown to cause a similar illness in the upper Midwest.

The FDA has approved Alyftrek (Vertex), an oral fixed-dose combination of the cystic fibrosis transmembrane conductance regulator (CFTR) modulators vanzacaftor, tezacaftor, and deutivacaftor, for once-daily treatment of cystic fibrosis (CF) in patients ≥6 years old who have at least one F508del mutation or another responsive mutation in the CFTR gene. This is the first approval for vanzacaftor and for deutivacaftor, a deuterated form of ivacaftor. Trikafta, a twice-daily oral fixed-dose combination of elexacaftor, tezacaftor, and ivacaftor, is FDA-approved for the same indication...

Plenity (Gelesis), a nonsystemic oral superabsorbent hydrogel formulation of cellulose and citric acid is now available. It was cleared by the FDA in 2019 to aid in weight management together with diet and exercise in overweight and obese adults (BMI of 25-40 kg/m2). It is classified by the FDA as a device because the contents of the capsule are not absorbed systemically. Plenity is the first ingested, transient, space-occupying hydrogel to be marketed in the US and the only weight management treatment available by prescription for patients with a BMI of 25-30 kg/m2, regardless of...

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.

The FDA has approved an expansion of the peripheral artery disease (PAD) indication for the oral direct factor Xa inhibitor rivaroxaban (Xarelto – Janssen) to include patients who have recently undergone a lower extremity revascularization procedure for symptomatic PAD (see Table 1). Rivaroxaban is the first direct oral anticoagulant (DOAC) to be approved for use in patients with PAD.

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.

Odevixibat (Bylvay – Albireo), an oral ileal bile acid transporter (IBAT) inhibitor, has been approved by the FDA for treatment of pruritus in patients ≥3 months old with progressive familial intrahepatic cholestasis (PFIC). It is the first drug to be approved in the US for this indication.

The FDA has approved Twyneo (Galderma), a cream containing the retinoid tretinoin and the oxidizing agent benzoyl peroxide, for once-daily topical treatment of acne in patients ≥9 years old.