Resmetirom (Rezdiffra – Madrigal), a thyroid hormone receptor-beta agonist, has received accelerated approval from the FDA for treatment of noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced fibrosis in adults. NASH has recently been renamed metabolic dysfunction-associated steatohepatitis (MASH). Resmetirom is the first drug to be approved in the US for this indication.

The FDA has approved perfluorohexyloctane ophthalmic solution (Miebo – Bausch+Lomb) for treatment of dry eye disease. Available only by prescription, Miebo is the first ophthalmic product to be approved in the US that specifically targets tear evaporation caused by meibomian gland dysfunction. An ophthalmic solution with a similar name, Meibo Tears (Vista), which contains 0.6% propylene glycol, is available over the counter for dry eye relief.

The FDA has approved the interleukin (IL)-6 inhibitor sarilumab (Kevzara – Sanofi/Regeneron) for treatment of polymyalgia rheumatica (PMR) in adults who had an inadequate response to corticosteroids or cannot tolerate a corticosteroid taper. Sarilumab is the first biologic drug to be approved for treatment of PMR; it was previously approved for treatment of rheumatoid arthritis.

The centuries-old anti-inflammatory drug colchicine (Colcrys, and others) is FDA-approved for prophylaxis and treatment of gout flares and for treatment of familial Mediterranean fever. It is also used off-label to treat pericarditis, and in recent years has been investigated for reduction of cardiovascular risk in patients with coronary artery disease (CAD).

The FDA has approved elacestrant (Orserdu – Stemline), an oral estrogen receptor antagonist, for treatment of estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer in postmenopausal women or men who had disease progression following endocrine therapy. Elacestrant is the first oral selective estrogen receptor degrader (SERD) to be approved for treatment of breast cancer; the injectable SERD fulvestrant (Faslodex, and generics) was approved more than 20 years...

The FDA has approved the complement factor B inhibitor iptacopan (Fabhalta – Novartis) for treatment of paroxysmal nocturnal hemoglobinuria (PNH) in adults. Iptacopan is the first oral drug to be approved in the US for this indication. Three parenterally administered drugs, the complement C5 inhibitors eculizumab (Soliris) and ravulizumab (Ultomiris) and the complement C3 inhibitor pegcetacoplan (Empaveli), are also approved for treatment of PNH.

TThe FDA has licensed mResvia (Moderna), an mRNA respiratory syncytial virus (RSV) vaccine, for prevention of lower respiratory tract disease (LRTD) caused by RSV in adults ≥60 years old. It is the first mRNA vaccine to be licensed in the US for this indication. Two recombinant RSV vaccines, Arexvy and Abrysvo, are also available for prevention of RSV LRTD. Arexvy is approved for use in adults ≥50 years old. Abrysvo is approved for use in adults ≥60 years old and in pregnant women to prevent RSV LRTD in their infants.

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...

The subcutaneously injected interleukin-13 (IL-13) antagonist tralokinumab-ldrm (Adbry – Leo) and the oral Janus kinase (JAK) inhibitors abrocitinib (Cibinqo – Pfizer) and upadacitinib (Rinvoq – Abbvie) have been approved by the FDA for treatment of moderate to severe atopic dermatitis.