The FDA has approved ganaxolone (Ztalmy – Marinus) for oral treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder in patients ≥2 years old. It is the first drug to be approved in the US for this indication.

The FDA has approved Seglentis (Esteve/Kowa), an oral combination of tramadol hydrochloride, a weak opioid agonist and weak serotonin and norepinephrine reuptake inhibitor (SNRI), and celecoxib, a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID), for use in adults with acute pain that is severe enough to require an opioid and for which alternative treatment options are inadequate.

The FDA has approved viloxazine extended-release capsules (Qelbree – Supernus) for treatment of attention-deficit/hyperactivity disorder (ADHD) in children 6-17 years old. Viloxazine is the second selective norepinephrine reuptake inhibitor to be approved in the US for treatment of ADHD; atomoxetine (Strattera, and generics) was approved in 2002.

The FDA has approved Ryaltris (Hikma), a fixed-dose combination nasal spray containing the H1-antihistamine olopatadine hydrochloride (Patanase, and generics) and the corticosteroid mometasone furoate (Nasonex 24 HR Allergy, and generics), for treatment of seasonal allergic rhinitis symptoms in persons ≥12 years old. Ryaltris is the second intranasal antihistamine/corticosteroid combination to be approved for this indication; azelastine 0.1%/fluticasone propionate (Dymista, and generics), which is approved for use in persons ≥6 years old, was the first. Both products are available...

View the Comparison Table: Some Drugs for Migraine Prevention in Adults

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 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 tirzepatide (Mounjaro – Lilly), a peptide hormone with activity at both glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors, to improve glycemic control in adults with type 2 diabetes. Tirzepatide, which is injected subcutaneously once weekly, is the first dual GIP/GLP-1 receptor agonist to become available in the US. Selective GIP receptor agonists are not available in the US; GLP-1 receptor agonists have been available for years.

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).