The FDA has approved the oral kinase inhibitor quizartinib (Vanflyta – Daiichi Sankyo) for use in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy in adults with FLT3 internal tandem duplication (ITD)-positive, newly-diagnosed acute myeloid leukemia (AML).

Inclisiran (Leqvio – Novartis), a subcutaneously injected small interfering RNA (siRNA) that decreases LDL-cholesterol (LDL-C) levels by reducing synthesis of proprotein convertase subtilisin/kexin type 9 (PCSK9), has been approved by the FDA for use with or without a statin to reduce LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Inclisiran had previously been approved for use only in combination with statin therapy.

The FDA has approved Tonmya (Tonix), a sublingual tablet formulation of the skeletal muscle relaxant cyclobenzaprine, for treatment of fibromyalgia in adults. Cyclobenzaprine is available in immediate-release tablets and extended-release capsules for short-term treatment of muscle spasms and has been used off-label for treatment of fibromyalgia.

American College of Cardiology/American Heart Association (ACC/AHA) guidelines for treatment of hypertension were last published in 2018. Treatment of hypertensive urgencies and emergencies is not discussed here.

The alkylating agent lurbinectedin (Zepzelca – Jazz) has received accelerated approval from the FDA for treatment of metastatic small-cell lung cancer (SCLC) in adults with disease progression on or after platinum-based chemotherapy. Accelerated approval was based on the overall response rate and duration of response. About 13-15% of lung cancers are small-cell cancers. Most SCLCs occur in patients who are current or former smokers.

Olutasidenib (Rezlidhia – Rigel), an oral isocitrate dehydrogenase-1 (IDH1) inhibitor, has been approved by the FDA for treatment of relapsed or refractory acute myeloid leukemia (AML) in adults with a susceptible IDH1 mutation. It is the second drug that targets cancer metabolism to be approved for this indication; ivosidenib (Tibsovo) was approved in 2022.

The CDC is recommending that persons at high risk of mpox (see Table 1) receive two doses of the Jynneos vaccine. The recommendation follows reports of a recent cluster of mpox cases in the US and warnings about the risk of a renewed outbreak during the spring and summer as people gather for festivals and other events. The CDC does not recommend routine immunization against mpox for the general population.

Lifileucel (Amtagvi – Iovance), a tumor-derived autologous T-cell immunotherapy, has received accelerated approval from the FDA for one-time treatment of adults with unresectable or metastatic melanoma previously treated with a programmed death receptor-1 (PD-1) inhibitor, and if BRAF V600 mutation-positive, a BRAF inhibitor with or without a mitogen-activated kinase (MEK) inhibitor. It is the first cellular therapy to be approved for use in solid tumors. Accelerated approval of lifileucel was based on objective response rates.

The FDA has approved tebentafusp-tebn (Kimmtrak – Immunocore), a first-in-class bispecific gp100 peptide-HLA-directed CD3 T-cell engager, for treatment of HLA-A*02:01-positive unresectable or metastatic uveal melanoma in adults.

Elecsys Phospho-Tau (181P) Plasma (Roche), a blood-based diagnostic test, has been cleared by the FDA to aid in the initial assessment of amyloid plaque pathology associated with Alzheimer's disease (AD) in patients ≥55 years old with signs of cognitive decline. It is the second blood test for AD biomarkers to be cleared by the FDA; the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test was cleared in 2025 (see Table 1).