The injectable interleukin (IL)-23 antagonist risankizumab-rzza (Skyrizi – Abbvie), previously approved by the FDA for treatment of Crohn's disease (CD), has now been approved for treatment of moderately to severely active ulcerative colitis (UC) in adults. Risankizumab is the first IL-23 antagonist to be approved for treatment of both CD and UC. It is also approved for treatment of plaque psoriasis and psoriatic arthritis.

The injectable glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Ozempic – Novo Nordisk) has been approved by the FDA to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease (CKD). It is the first GLP-1 receptor agonist to be approved in the US for this indication.

The FDA has approved oral and injectable formulations of the HIV-1 capsid inhibitor lenacapavir (Yeztugo – Gilead) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in at-risk adolescents and adults. Lenacapavir is the first drug to be approved for this indication that is given twice-yearly; other drugs approved for this indication are given once daily or once every 2 months. Lenacapavir was approved in 2022 as Sunlenca for use with other antiretroviral drugs to treat multidrug-resistant HIV-1 infection (MDR-HIV) in heavily treatment-experienced...

Most patients with multiple sclerosis (MS) present with the relapsing-remitting form of the disease. Pharmacologic treatment usually includes a disease-modifying drug, corticosteroids for acute exacerbations, and other drugs for managing symptoms such as fatigue, depression, and pain. Early use of disease-modifying therapy has improved clinical outcomes.

Psoriatic arthritis is a chronic inflammatory arthropathy associated with psoriasis. A recent review found that about 20% of patients with psoriasis have psoriatic arthritis. Updated guidelines for treatment of psoriatic arthritis have recently been published.

The FDA has approved semaglutide (Ozempic – Novo Nordisk), a long-acting injectable GLP-1 (glucagon-like peptide-1) receptor agonist, for once-weekly treatment of adults with type 2 diabetes. It is the sixth GLP-1 receptor agonist to be approved in the US.

The FDA has approved cefiderocol (Fetroja – Shionogi), a new IV cephalosporin antibiotic, for treatment of complicated urinary tract infections (UTI) caused by susceptible gram-negative bacteria in adults who have limited or no alternative treatment options.

Artesunate for injection (Amivas LLC), a semi-synthetic artemisinin derivative, is now approved by the FDA for initial (induction) treatment of severe malaria in children and adults. It has been available from the CDC on a compassionate use basis since 2007. Artemether/lumefantrine (Coartem), another artemisinin-based drug, was approved earlier for oral treatment of uncomplicated Plasmodium falciparum malaria. IV artesunate is now the only FDA-approved injectable antimalarial drug available in the US; IV quinidine has been discontinued.

The FDA has approved peginterferon alfa-2b (Sylatron – Merck) for adjuvant treatment of node-positive melanoma after surgical resection. Pegylated interferon has a longer duration of action than interferon alfa-2b (Intron A), which is also FDA-approved for adjuvant treatment of malignant melanoma after surgery, and can be given once a week, compared to 3-5 times a week for standard interferon.

The FDA has approved Juvisync (Merck), a fixed-dose combination of the antihyperglycemic DPP-4 inhibitor sitagliptin (Januvia) and the HMG-CoA reductase inhibitor simvastatin (Zocor, and others).