Afamitresgene autoleucel (Tecelra – Adaptimmune), a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T-cell immunotherapy, has received accelerated approval from the FDA for one-time treatment of adults with unresectable or metastatic synovial sarcoma who received prior chemotherapy and are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen. It is the first gene therapy to be approved in the US for treatment of synovial sarcoma. Accelerated approval of the immunotherapy was based on the...

The FDA has authorized use of Teal Wand (Teal Health), an at-home vaginal sample self-collection device, for cervical cancer screening.

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 FDA has approved Xifyrm (Azurity) and Qamzova (Nanjing Delova), two new intravenous (IV) formulations of the nonsteroidal anti-inflammatory drug (NSAID) meloxicam, for use alone or in combination with non-NSAID analgesics for treatment of moderate to severe pain in adults. Anjeso, the first IV formulation of meloxicam, was discontinued in 2022 for commercial reasons.

The FDA has approved the dual endothelin receptor antagonist aprocitentan (Tryvio – Idorsia) for use in combination with other antihypertensive drugs to treat hypertension in adults whose blood pressure is not adequately controlled on other drugs. Three other dual endothelin receptor antagonists, ambrisentan (Volibris, and generics), bosentan (Tracleer, and generics), and macitentan (Opsumit), are available in the US for treatment of pulmonary arterial hypertension.

FluMist (AstraZeneca), the live-attenuated intranasal influenza vaccine that has been available for years for administration by a healthcare provider in nonpregnant persons 2-49 years old, has now been approved by the FDA for self- or caregiver-administration. It is expected to be available for such use during the 2025-2026 influenza season. FluMist is only available through a healthcare provider this season. It will continue to be available for administration by a healthcare provider in the future

The FDA has approved ritlecitinib (Litfulo – Pfizer), an oral JAK and TEC kinase family inhibitor, for treatment of severe alopecia areata in patients ≥12 years old. Ritlecitinib is the second oral drug to be approved in the US for treatment of severe alopecia areata; baricitinib (Olumiant), a JAK inhibitor, is approved only for use in adults.

The FDA has approved the interleukin (IL)-23 antagonist mirikizumab-mrkz (Omvoh – Lilly) for treatment of moderately to severely active ulcerative colitis (UC) in adults. Mirikizumab is the first selective IL-23 antagonist to be approved for this indication. Ustekinumab (Stelara), an IL-12/23 antagonist, was approved for treatment of UC in 2019. The IL-23 antagonist risankizumab (Skyrizi) is approved for treatment of Crohn's disease.

View the Comparison Table: Some Lipid-Lowering Drugs

Mild to moderate plaque psoriasis can be treated with topical drugs and phototherapy. Patients with moderate to severe disease generally require systemic therapy. Guidelines for the treatment of psoriasis with topical therapy, phototherapy, and systemic drugs have recently been published.