The FDA has approved a 0.15% cream formulation of the phosphodiesterase-4 (PDE4) inhibitor roflumilast (Zoryve – Arcutis) for topical treatment of mild to moderate atopic dermatitis (AD) in patients ≥6 years old. Roflumilast is the second PDE4 inhibitor to be approved in the US for treatment of AD; crisaborole (Eucrisa), which can be used in patients ≥3 months old, was the first. Roflumilast is available as Zoryve in a 0.3% cream for treatment of plaque psoriasis and a 0.3% foam for treatment of seborrheic dermatitis. It is also available in an oral formulation (Daliresp) for...

The potassium-competitive acid blocker vonoprazan (Voquezna – Phathom), which was approved earlier for treatment of erosive esophagitis, has now been approved by the FDA for relief of heartburn associated with nonerosive gastroesophageal reflux disease (GERD) in adults. Vonoprazan is also available copackaged with amoxicillin (Voquezna Dual Pak) and with amoxicillin and clarithromycin (Voquezna Triple Pak) for treatment of Helicobacter pylori infection.

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.

Elinzanetant (Lynkuet – Bayer), a first-in-class neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist, has been approved by the FDA for treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. Fezolinetant (Veozah), an NK3 receptor antagonist, was approved for the same indication in 2023.

The FDA has approved gepotidacin (Blujepa – GSK), a triazaacenaphthylene bacterial type II topoisomerase inhibitor, for oral treatment of uncomplicated urinary tract infections (uUTI) in female patients ≥12 years old who weigh ≥40 kg. Gepotidacin is the first triazaacenaphthylene antibiotic to be approved in the US.

The FDA has approved Rebyota (Ferring), a rectally-administered, live fecal microbiota suspension, for prevention of additional recurrences of Clostridioides difficile infection (CDI) following antibiotic treatment for a recurrent episode of CDI in adults. Rebyota is the first microbiome-based treatment to be approved for this indication. It is not approved for initial treatment of CDI. Fecal microbiota transplantation (FMT) has been used in patients with multiple CDI recurrences.

Toripalimab-tpzi (Loqtorzi – Coherus Biosciences), a programmed death receptor-1 (PD-1)-blocking antibody, has been approved by the FDA for use in combination with cisplatin and gemcitabine for first-line treatment of recurrent locally advanced or metastatic nasopharyngeal carcinoma and for use as monotherapy for treatment of recurrent unresectable or metastatic nasopharyngeal carcinoma in adults with disease progression on or after platinum-based chemotherapy. It is the first immune checkpoint inhibitor to be approved in the US for treatment of nasopharyngeal carcinoma.

Resmetirom (Rezdiffra – Madrigal), a thyroid hormone receptor-beta agonist, has received accelerated approval from the FDA for treatment of noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced fibrosis in adults. NASH has recently been renamed metabolic dysfunction-associated steatohepatitis (MASH). Resmetirom is the first drug to be approved in the US for this indication.

Mepolizumab (Nucala – GSK), a subcutaneously injected interleukin-5 (IL-5) antagonist, has been approved by the FDA for add-on maintenance treatment of adults who have inadequately controlled chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype. Mepolizumab is also approved for treatment of asthma, chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis, and hypereosinophilic syndrome.

The FDA has approved remibrutinib (Rhapsido – Novartis), an oral Bruton's tyrosine kinase (BTK) inhibitor, for treatment of chronic spontaneous urticaria in adults who remain symptomatic despite H₁-antihistamine treatment. Remibrutinib is the first oral drug to be approved in the US for this indication.