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.

The FDA has approved lerodalcibep (Lerochol – Lib Therapeutics), a subcutaneously injected proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Lerodalcibep is the fourth subcutaneously injected PCSK9-directed therapy to be approved in the US; the monoclonal antibodies alirocumab (Praluent) and evolocumab (Repatha) and the small interfering RNA inclisiran (Leqvio) were approved earlier (see Table...

The main goals of treatment of chronic obstructive pulmonary disease (COPD) are to relieve symptoms, reduce the frequency and severity of exacerbations, prevent disease progression, and reduce mortality. GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelines for treatment of COPD were updated recently. Treatment of acute exacerbations is not discussed here. Drugs available for treatment of COPD are listed in Tables 1 and 3.

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 two new oral formulations of testosterone undecanoate — Kyzatrex (Marius) and Tlando (Antares) — for treatment of males with a deficiency of endogenous testosterone due to conditions such as Klinefelter syndrome, orchiectomy, toxic damage from chemotherapy or alcohol, or pituitary-hypothalamic injury caused by tumors, trauma, or radiation. Jatenzo, another oral testosterone undecanoate formulation, was approved for the same indication in 2019. No testosterone products are approved for treatment of low testosterone levels due solely to...

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.

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.

The FDA has approved sotatercept-csrk (Winrevair – Merck), a first-in-class activin signaling inhibitor, to increase exercise capacity, improve WHO functional class, and reduce the risk of clinical worsening events in adults with WHO Group 1 pulmonary arterial hypertension (PAH).

The FDA has approved rezafungin (Rezzayo – Cidara/Melinta), an intravenous echinocandin antifungal, for once-weekly treatment of candidemia and invasive candidiasis (IC) in adults with limited or no alternative options. It is the first new drug to become available in the US in more than 15 years for treatment of systemic Candida infections.