The FDA has approved mavacamten (Camzyos – MyoKardia/BMS), a modulator of cardiac myosin, to improve functional capacity and symptoms in adults with New York Heart Association (NYHA) class II or III obstructive hypertrophic cardiomyopathy (HCM) who have a baseline left ventricular ejection fraction (LVEF) ≥55%. Mavacamten is the first drug in its class to become available in the US.

The FDA has approved tenapanor (Ibsrela - Ardelyx), a sodium/hydrogen exchanger 3 (NHE3) inhibitor, for twice-daily oral treatment of irritable bowel syndrome with constipation (IBS-C) in adults. Tenapanor is the first NHE3 inhibitor to become available in the US.

The FDA has approved tirzepatide (Mounjaro – Lilly), a peptide hormone with activity at both glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors, to improve glycemic control in adults with type 2 diabetes. Tirzepatide, which is injected subcutaneously once weekly, is the first dual GIP/GLP-1 receptor agonist to become available in the US. Selective GIP receptor agonists are not available in the US; GLP-1 receptor agonists have been available for years.

The FDA has approved oteseconazole (Vivjoa – Mycovia), a new oral azole antifungal, to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC. Oteseconazole is the first drug to be approved in the US specifically for treatment of RVVC.

The FDA has approved the oral Janus kinase (JAK) inhibitor upadacitinib (Rinvoq – Abbvie) for treatment of moderately to severely active ulcerative colitis in adults who have had an inadequate response to or cannot tolerate one or more tumor necrosis factor (TNF) inhibitors. Upadacitinib is the second JAK inhibitor to be approved for this indication; tofacitinib (Xeljanz) was the first. Upadacitinib is also approved for treatment of rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, and ankylosing spondylitis.

The injectable interleukin (IL)-23 antagonist risankizumab-rzaa (Skyrizi – Abbvie) has been approved by the FDA for treatment of moderately to severely active Crohn's disease (CD) in adults. Risankizumab was approved earlier for treatment of plaque psoriasis and psoriatic arthritis.

The FDA has approved the subcutaneously injected interleukin (IL)-4 receptor alpha antagonist dupilumab (Dupixent – Sanofi/Regeneron) for treatment of eosinophilic esophagitis (EoE) in patients ≥12 years old who weigh ≥40 kg and treatment of prurigo nodularis in adults. Dupilumab is the first drug to be approved in the US for each of these indications. It is also FDA-approved for treatment of atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis.

The FDA has approved daprodustat (Jesduvroq – GSK), a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for oral treatment of anemia due to chronic kidney disease (CKD) in adults who have been on dialysis for at least 4 months. It is the first HIF-PHI and the first oral drug to be approved in the US for this indication.

Rozanolixizumab-noli (Rystiggo – UCB), a neonatal Fc receptor (FcRn) blocker, has been approved by the FDA for treatment of generalized myasthenia gravis in adults with anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibodies. It is the first drug to be approved for treatment of generalized myasthenia gravis in patients with anti-MuSK antibodies. Four other biologic drugs – the FcRn blocker efgartigimod alfa (Vyvgart; Vyvgart Hytrulo) and the complement inhibitors eculizumab (Soliris), ravulizumab (Ultomiris), and zilucoplan (Zilbrysq) – are...

The FDA has approved Airsupra (AstraZeneca), a metered-dose inhaler containing the short-acting beta₂-agonist (SABA) albuterol and the inhaled corticosteroid (ICS) budesonide, for use as needed for treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in patients ≥18 years old with asthma. Airsupra is the first combination of a SABA and an ICS to become available in the US. It is not approved for use as maintenance therapy.