Since our initial review of the oral lipid-lowering adenosine triphosphate-citrate lyase (ACL) inhibitor bempedoic acid (Nexletol – Esperion) in 2020, cardiovascular outcomes data in statin-intolerant patients have become available.

The oral kinase inhibitor futibatinib (Lytgobi – Taiho) has received accelerated approval from the FDA for treatment of adults with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma with fibroblast growth factor receptor 2 (FGFR2) fusions or other rearrangements. Accelerated approval was based on the overall response rate and duration of response. Futibatinib is the second drug to be approved for this indication; pemigatinib (Pemazyre) was approved earlier.

Results from a double-blind trial suggest that off-label use of the oral antihyperglycemic drug metformin in patients with COVID-19 may decrease the risk of post-acute sequelae of SARS-CoV-2 infection ("long COVID").

Tisotumab vedotin-tftv (Tivdak – Seagen/Genmab), a tissue factor-directed antibody and microtubule inhibitor conjugate, has received full approval from the FDA for treatment of recurrent or metastatic cervical cancer that progressed on or after chemotherapy. It is the first antibody-drug conjugate to be approved for treatment of cervical cancer. The drug received accelerated approval from the FDA in 2021 for the same indication.

Lazertinib (Lazcluze – Janssen Biotech), an oral kinase inhibitor, has been approved by the FDA for use in combination with the EGFR-MET bispecific antibody amivantamab (Rybrevant) for first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations. This is the first approval for Lazcluze; amivantamab was previously approved for use alone and in combination with carboplatin and pemetrexed for treatment of NSCLC with EGFR exon 20 insertion...

View Expanded Table: Some Conventional DMARDs for Rheumatoid Arthritis

Concizumab (Alhemo – Novo Nordisk), a subcutaneously injected tissue factor pathway inhibitor (TFPI) antagonist, has been approved by the FDA for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients ≥12 years old who have hemophilia A with factor VIII inhibitors or hemophilia B with factor IX inhibitors. It is the second TFPI antagonist to be approved in the US for treatment of hemophilia A or B; the TFPI antagonist marstacimab (Hympavzi) is approved for use in patients without inhibitors.

Onapgo (Supernus), a solution for continuous subcutaneous infusion containing the dopamine agonist apomorphine, has been approved by the FDA for treatment of motor fluctuations in adults with advanced Parkinson's disease (PD). Subcutaneously injected apomorphine (Apokyn, and generics) has been available for intermittent use for years. Vyalev, a foscarbidopa/foslevodopa solution for subcutaneous infusion, was approved in 2024 for the same indication.

Ziftomenib (Komzifti – Kura), an oral menin inhibitor, has been approved by the FDA for treatment of adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options. It is the second oral menin inhibitor to be approved in the US for this indication; revumenib (Revuforj) was approved in October 2025 for use in patients ≥1 year old.

The oral Janus kinase (JAK) inhibitor baricitinib (Olumiant – Lilly), which was previously approved by the FDA for treatment of moderately to severely active rheumatoid arthritis and treatment of COVID-19 in certain hospitalized adults, has now been approved for treatment of severe alopecia areata in adults. Baricitinib is the first systemic treatment to be approved in the US for this indication.