The FDA has approved orforglipron (Foundayo – Lilly), an oral small-molecule, nonpeptide glucagon-like peptide-1 (GLP-1) receptor agonist, to reduce excess body weight and maintain weight reduction long term in adults with obesity, or with overweight and at least one weight-related comorbidity. Orforglipron is the second oral GLP-1 receptor agonist to be approved in the US for this indication; an oral formulation of the peptide semaglutide (Wegovy) was approved in 2025.

Enlicitide (Lipfendra – Merck), an oral proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitor, has been approved by the FDA to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). It is the first oral PCSK9 inhibitor to be approved in the US; the other FDA-approved PCSK9 inhibitors (alirocumab [Praluent], evolocumab [Repatha], and lerodalcibep [Lerochol]) and the PCSK9-directed small interfering RNA inclisiran (Leqvio) are injected subcutaneously. Lipfendra was approved under...

Clostridioides (formerly Clostridium) difficile infection (CDI) is the most common infectious cause of healthcare-associated diarrhea in adults. Guidelines on management of CDI have recently been updated.

In overactive bladder, involuntary bladder contractions due to detrusor overactivity result in urinary urgency, frequency, nocturia, and incontinence. The prevalence of the disorder increases with age. Nonpharmacologic treatment, including bladder training, urge suppression, pelvic floor muscle exercises, constipation management, modification of fluid intake, and avoidance of dietary irritants such as alcohol and caffeine, should be tried first.

Age-related macular degeneration (AMD) has two major forms: dry or non-neovascular (~90% of patients) and wet or neovascular (~10% of patients).

Drugs for gout are used to reduce the pain and inflammation of acute flares, decrease the frequency of exacerbations, and lower serum urate levels to prevent recurrent flares, development of tophi, and joint damage.

Invega Hafyera (Janssen), a long-acting, extended-release (ER) formulation of the second-generation antipsychotic paliperidone palmitate, has been approved by the FDA for twice-yearly IM treatment of schizophrenia in adults who have been adequately treated with another injectable ER formulation of the drug (Invega Sustenna or Invega Trinza). It is the first drug to become available in the US for twice-yearly treatment of schizophrenia.

Difelikefalin (Korsuva – Vifor), an IV kappa opioid receptor (KOR) agonist, has been approved by the FDA for treatment of moderate to severe pruritus associated with chronic kidney disease (CKD) in adults on hemodialysis. It is the first drug to be approved for this indication and the first KOR agonist to become available in the US. Difelikefalin has not been studied in patients on peritoneal dialysis.

The FDA has approved a higher-dose injectable formulation of the opioid antagonist naloxone (Zimhi – Adamis) for emergency treatment of opioid overdose. A single IM or SC injection of the new formulation delivers 5 mg of naloxone; injectable formulations that deliver 0.4 mg or 2 mg of the drug have been available for years. Naloxone is also available in intranasal formulations for the same indication (see Table 1).

Efgartigimod alfa-fcab (Vyvgart – Argenx), a first-in-class neonatal Fc receptor (FcRn) antagonist, has been approved by the FDA for IV treatment of generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive. The IV complement inhibitor eculizumab (Soliris) was approved for the same indication in 2017.