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 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 the CD19-directed cytolytic antibody inebilizumab (Uplizna – Amgen) for IV treatment of generalized myasthenia gravis (gMG) in adults with anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibodies. The neonatal Fc receptor (FcRn) blockers rozanolixizumab (Rystiggo), nipocalimab (Imaavy), and efgartigimod alfa (Vyvgart; Vyvgart Hytrulo) are also approved for such use (see Table 1).

Gastroesophageal reflux disease (GERD) is the most common GI condition encountered in the outpatient setting; it affects about 20% of people in the US.

Breztri Aerosphere (AstraZeneca), a three-drug inhaler containing the inhaled corticosteroid (ICS) budesonide, the long-acting antimuscarinic agent (LAMA) glycopyrrolate, and the long-acting beta2-agonist (LABA) formoterol fumarate, has been approved by the FDA for maintenance treatment of asthma in patients ≥12 years old. It was approved in 2020 for treatment of chronic obstructive pulmonary disease (COPD). Breztri Aerosphere is the second ICS/LAMA/LABA combination to become available for treatment of asthma. Trelegy Ellipta, which contains the ICS fluticasone, the...

Irritable bowel syndrome (IBS) is a common disorder characterized by recurrent abdominal pain and altered bowel habits, often accompanied by bloating. IBS is classified by its predominant bowel symptom: constipation (IBS-C), diarrhea (IBS-D), mixed type (IBS-M), or unclassified (IBS-U). Since the exact cause of IBS is unknown, the goal of treatment is symptom control. Some over-the-counter (OTC) products and prescription drugs for IBS are listed in Tables 1-4. The safety of these drugs during pregnancy and lactation is described in Table 5 (online only).

The FDA has approved nirsevimab-alip (Beyfortus – AstraZeneca/Sanofi), a long-acting monoclonal antibody, for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children ≤24 months old who are at increased risk for severe RSV disease through their second RSV season. Nirsevimab is the first drug to be approved for protection of all infants during their first RSV season.

The oral second-generation antipsychotic drug iloperidone (Fanapt – Vanda) has been approved by the FDA for acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. First approved in 2009 for treatment of schizophrenia, iloperidone is the eighth second-generation antipsychotic to be approved for acute treatment of manic or mixed episodes of bipolar I disorder (see Table 1).

A reader of our article on the 2024-2025 formulations of the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) asked us to provide more information on the data that supported their licensure.

An outbreak of monkeypox has recently spread around the globe and across the US. Updated information about the current outbreak is available from the CDC.