The injectable glucose-dependent insulinotropic polypeptide (GIP)/glucagon-like peptide-1 (GLP-1) receptor agonist tirzepatide, which was approved by the FDA as Mounjaro for treatment of type 2 diabetes in 2022, has now been approved as Zepbound (Lilly) for chronic weight management in adults who have a BMI ≥30 kg/m2 or a BMI ≥27 kg/m2 and at least one weight-related comorbidity. The injectable GLP-1 receptor agonists liraglutide (Saxenda) and semaglutide (Wegovy) are approved for chronic weight management in patients ≥12 years...

Seladelpar (Livdelzi – Gilead), a peroxisome proliferator-activated receptor (PPAR)-delta agonist, has received accelerated approval from the FDA for use in combination with ursodeoxycholic acid (ursodiol, UDCA; Urso Forte, and generics) for treatment of primary biliary cholangitis (PBC) in adults who had an inadequate response to UDCA and as monotherapy in those unable to tolerate UDCA. Accelerated approval was based on a reduction in alkaline phosphatase (ALP) levels. Seladelpar is the second PPAR agonist to be approved in the US for this indication; elafibranor (Iqirvo)...

The FDA has approved the hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) vadadustat (Vafseo – Akebia) for oral treatment of anemia due to chronic kidney disease (CKD) in adults who have been on dialysis for at least 3 months. Vadadustat is the second HIF-PHI to be approved in the US for this indication; daprodustat (Jesduvroq) was approved earlier, but it was withdrawn from the US market in 2024 for commercial reasons.

The interleukin (IL)-23 antagonist guselkumab (Tremfya – Janssen Biotech) has now been approved by the FDA for treatment of moderately to severely active ulcerative colitis (UC) in adults; it was approved earlier for treatment of plaque psoriasis and psoriatic arthritis. Guselkumab is the third IL-23 antagonist to be approved in the US for treatment of UC; risankizumab (Skyrizi) and mirikizumab (Omvoh) were approved earlier.

The injectable interleukin (IL)-23 antagonist mirikizumab-mrkz (Omvoh – Lilly) is now FDA-approved for treatment of moderately to severely active Crohn's disease (CD) in adults. Mirikizumab was approved in 2023 for treatment of ulcerative colitis. Two other IL-23 antagonists, risankizumab (Skyrizi) and guselkumab (Tremfya), are also approved for treatment of CD.

The FDA has approved clesrovimab-cfor (Enflonsia – Merck), a long-acting monoclonal antibody, for prevention of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in neonates and infants born during or entering their first RSV season. Clesrovimab is the second drug to be approved for this indication; nirsevimab (Beyfortus), another long-acting monoclonal antibody, was the first. Palivizumab (Synagis), a shorter-acting antibody, is FDA-approved for prevention of severe RSV LRTI in certain high-risk children ≤24 months old.

The FDA has approved a 2% cream formulation of delgocitinib (Anzupgo – Leo), a Janus kinase (JAK) inhibitor, for treatment of moderate to severe chronic hand eczema (dermatitis) in adults who had an inadequate response to or are unable to use topical corticosteroids. Delgocitinib is the first drug to be approved in the US for this indication. Ruxolitinib, another JAK inhibitor, is available in a 1.5% cream formulation (Opzelura) for treatment of mild to moderate atopic dermatitis in patients ≥2 years old.

The FDA has approved the oral Janus kinase (JAK) inhibitor deuruxolitinib (Leqselvi – Sun) for treatment of severe alopecia areata in adults. Two other oral JAK inhibitors are approved for treatment of severe alopecia areata: baricitinib (Olumiant) is approved for use in adults, and ritlecitinib (Litfulo) is approved for use in patients ≥12 years old.

The FDA has approved depemokimab (Exdensur – GSK), a long-acting interleukin-5 (IL-5) antagonist, for add-on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in patients ≥12 years old. Depemokimab is the fourth IL-5-directed treatment to be approved in the US for this indication; the IL-5 antagonists mepolizumab (Nucala) and reslizumab (Cinqair) and the IL-5 receptor alpha antagonist benralizumab (Fasenra) were approved earlier.

The FDA has approved pivmecillinam (Pivya – Utility Therapeutics), an oral penicillin-class antibacterial drug, for treatment of uncomplicated urinary tract infections (uUTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis, or Staphylococcus saprophyticus in adult females. Pivmecillinam was approved by the FDA in 2024 but only recently became available in the US. It has been used in Europe for over 40 years.