The FDA has approved a subcutaneous formulation of the recombinant human anti-CD20 antibody ofatumumab (Kesimpta – Novartis) for treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (initial neurological episode), relapsing-remitting disease, and active secondary progressive MS (SPMS). Kesimpta is the second anti-CD20 antibody to be approved for these indications; IV ocrelizumab (Ocrevus), which is also approved for treatment of primary progressive MS, was the first. An IV formulation of ofatumumab (Arzerra) has...

The FDA has approved a 0.3% foam formulation of the phosphodiesterase-4 (PDE4) inhibitor roflumilast (Zoryve – Arcutis) for topical treatment of seborrheic dermatitis in patients ≥9 years old. Roflumilast is the first PDE4 inhibitor to be approved in the US for this indication. It is also available in a 0.3% cream formulation (Zoryve) for treatment of plaque psoriasis and in an oral formulation (Daliresp, and generics) for treatment of chronic obstructive pulmonary disease. A 0.15% cream formulation for treatment of atopic dermatitis in patients ≥6 years old will be reviewed...

The FDA has approved eptinezumab-jjmr (Vyepti – Lundbeck), a calcitonin gene-related peptide (CGRP) antagonist administered IV once every 3 months, for migraine prevention in adults. It is the fourth monoclonal antibody to be approved for this indication; erenumab (Aimovig), fremanezumab (Ajovy), and galcanezumab (Emgality), which are all given subcutaneously once monthly (fremanezumab can also be given once every 3 months), were approved earlier.

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...

The FDA has approved the complement C5 inhibitor zilucoplan (Zilbrysq – UCB) for once-daily subcutaneous treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive. Zilucoplan is the first complement inhibitor to be approved for treatment of myasthenia gravis that can be self-administered. Two IV complement inhibitors, eculizumab (Soliris) and ravulizumab (Ultomiris), were approved earlier.

The FDA has approved mavacamten (Camzyos – MyoKardia/BMS), a modulator of cardiac myosin, to improve functional capacity and symptoms in adults with New York Heart Association (NYHA) class II or III obstructive hypertrophic cardiomyopathy (HCM) who have a baseline left ventricular ejection fraction (LVEF) ≥55%. Mavacamten is the first drug in its class to become available in the US.

Rozanolixizumab-noli (Rystiggo – UCB), a neonatal Fc receptor (FcRn) blocker, has been approved by the FDA for treatment of generalized myasthenia gravis in adults with anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibodies. It is the first drug to be approved for treatment of generalized myasthenia gravis in patients with anti-MuSK antibodies. Four other biologic drugs – the FcRn blocker efgartigimod alfa (Vyvgart; Vyvgart Hytrulo) and the complement inhibitors eculizumab (Soliris), ravulizumab (Ultomiris), and zilucoplan (Zilbrysq) – are...

The FDA has approved rezafungin (Rezzayo – Cidara/Melinta), an intravenous echinocandin antifungal, for once-weekly treatment of candidemia and invasive candidiasis (IC) in adults with limited or no alternative options. It is the first new drug to become available in the US in more than 15 years for treatment of systemic Candida infections.

The FDA has approved ozanimod (Zeposia – Celgene), a sphingosine 1-phosphate (S1P) receptor modulator, for treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (initial neurological episode), relapsing-remitting disease, and active secondary progressive MS (SPMS). It is the third oral S1P receptor modulator to be approved in the US for treatment of relapsing forms of MS; siponimod (Mayzent) is also indicated for use in adults, and fingolimod (Gilenya) is approved for use in patients ≥10 years old.

The FDA has licensed the pentavalent vaccine Penmenvy (GSK) for prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, B, C, W, or Y (MenABCWY) in persons 10-25 years old. Penmenvy is the second pentavalent meningococcal vaccine to become available in the US; Penbraya was licensed in 2023.