On September 22, on the advice of its Vaccines and Related Biologic Products Advisory Committee, the FDA expanded the Emergency Use Authorization (EUA) for the Pfizer/BioNTech mRNA-based COVID-19 vaccine (Comirnaty) to include administration of a booster dose ≥6 months after a 2-dose primary series in adults who are ≥65 years old or at high risk for severe COVID-19 because of an underlying medical condition or frequent institutional or occupational exposure to SARS-CoV-2 (see Table 1). The FDA Advisory Committee recommended against authorization of a booster dose of Comirnaty...

The FDA has approved inclisiran (Leqvio – Novartis), a small interfering RNA (siRNA) directed to proprotein convertase subtilisin/kexin type 9 (PCSK9) mRNA, as an adjunct to diet and maximally tolerated statin therapy for subcutaneous (SC) treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low-density lipoprotein cholesterol (LDL-C). Inclisiran is the first FDA-approved PCSK9-directed siRNA therapeutic agent.

The FDA has approved the recombinant chimeric anti-CD20 antibody ublituximab-xiiy (Briumvi – TG Therapeutics) for IV 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). Two other anti-CD20 antibodies, IV ocrelizumab (Ocrevus) and SC ofatumumab (Kesimpta), are also FDA-approved for these indications.

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 recombinant respiratory syncytial virus (RSV) vaccine Arexvy (GSK) has now received FDA approval for use in adults 50-59 years old who are at increased risk for lower respiratory tract disease (LRTD) caused by RSV. It was previously approved only for adults ≥60 years old. Two other RSV vaccines have received FDA approval: Abrysvo, a recombinant vaccine that is licensed for use in adults ≥60 years old and in pregnant women at 32-36 weeks' gestation to prevent RSV-associated LRTD in their infants, and mResvia, an mRNA vaccine recently licensed for use in adults ≥60 years old...

The FDA has approved the hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) vadadustat (Vafseo – Akebia) for oral treatment of anemia due to chronic kidney disease (CKD) in adults who have been on dialysis for at least 3 months. Vadadustat is the second HIF-PHI to be approved in the US for this indication; daprodustat (Jesduvroq) was approved earlier, but it was withdrawn from the US market in 2024 for commercial reasons.

View the Comparison Table: Antiviral Drugs for Seasonal Influenza for 2025-2026

The FDA has approved changes to the wording of the cardiovascular risk reduction indications for the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors evolocumab (Repatha) and alirocumab (Praluent). Both drugs are now approved to reduce the risk of major adverse cardiovascular events (MACE) in adults at increased risk for these events; they were previously approved to reduce the risk of MACE only in patients with established cardiovascular disease (CVD).

The FDA has approved the second-generation antipsychotic drug lumateperone (Caplyta — Intra-Cellular Therapies) for adjunctive treatment of major depressive disorder (MDD) in adults. Lumateperone was approved earlier for treatment of schizophrenia and bipolar depression.

The FDA has approved pivmecillinam (Pivya – Utility Therapeutics), an oral penicillin-class antibacterial drug, for treatment of uncomplicated urinary tract infections (uUTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis, or Staphylococcus saprophyticus in adult females. Pivmecillinam was approved by the FDA in 2024 but only recently became available in the US. It has been used in Europe for over 40 years.