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Annual influenza vaccination is recommended for all persons ≥6 months old without a contraindication. Influenza vaccines available this season in the US are listed in Table 3.

The injectable GIP/GLP-1 receptor agonist tirzepatide (Mounjaro – Lilly), which was approved by the FDA in 2022 for treatment of type 2 diabetes, has now been approved to reduce the risk of MACE in adults with type 2 diabetes who are at high risk for these events. Tirzepatide is also available as Zepbound for chronic weight management and for treatment of obstructive sleep apnea in adults with obesity.

The FDA has licensed 2026-2027 formulas of the mRNA COVID-19 vaccines Comirnaty, Spikevax, and mNEXSPIKE and the adjuvanted protein subunit COVID-19 vaccine Nuvaxovid.

The rapid-acting inhaled human insulin Afrezza (MannKind), which was approved in 2014 for treatment of type 1 or type 2 diabetes in adults, has now been approved by the FDA for use in children ≥6 years old.

Lunsotogene parvec (Otarmeni – Regeneron), an adeno-associated viral vector-based gene therapy, has received accelerated approval from the FDA for treatment of severe-to-profound or profound sensorineural hearing loss (any frequency >90 decibels hearing level [dB HL]) in patients with confirmed variants in both copies of the otoferlin (OTOF) gene. It is the first gene therapy to be approved in the US for genetic hearing loss.

The kinase inhibitor gedatolisib (Revtorpyk – Celcuity) has been approved by the FDA for use in combination with fulvestrant, with or without the cyclin-dependent kinase (CDK) 4/6 inhibitor palbociclib (Ibrance), for treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation in adults who had disease progression on or after at least one prior line of endocrine therapy for metastatic disease.

Vusolimogene oderparepvec (Tudriqev – Replimune), a genetically-modified herpes simplex virus type 1 (HSV-1) oncolytic therapy, has been granted accelerated approval by the FDA for use in combination with the programmed death receptor-1 (PD-1)-blocking antibody nivolumab (Opdivo) for treatment of unresectable advanced cutaneous melanoma in adults who had disease progression on a PD-1-blocking antibody-based regimen. About 30-50% of patients develop primary resistance to anti-PD-1 therapy. The oncolytic viral therapy talimogene laherparepvec (Imlygic) was approved in 2015 for treatment of patients with melanoma recurrence postsurgery.

The FDA has approved tezepelumab (Tezspire – Amgen/AstraZeneca), a subcutaneously administered thymic stromal lymphopoietin (TSLP) blocker, for add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in patients ≥12 years old. It is the first TSLP blocker to be approved for this indication. Tezepelumab was approved for add-on maintenance treatment of severe asthma in 2021.

Camizestrant (Etcamah – AstraZeneca), an oral estrogen receptor antagonist, has received accelerated approval from the FDA for use in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor for treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer in adults who have ESR1 mutations that were detected in circulating tumor DNA (ctDNA) during treatment with an aromatase inhibitor and a CDK 4/6 inhibitor.

Iberdomide (Zenbexus – BMS), an oral first-in-class cereblon-modulating protein degrader, has received accelerated approval from the FDA for use in combination with the CD38-directed cytolytic antibody daratumumab (Darzalex Faspro) and dexamethasone for treatment of multiple myeloma in adults who received at least one prior line of therapy, including a proteasome inhibitor (e.g., bortezomib) and an immunomodulatory drug. The drug was approved based on a surrogate endpoint of minimal residual disease-negative complete response.