The interleukin-6 (IL-6) receptor antagonist tocilizumab (Actemra – Genentech) has been approved by the FDA for IV treatment of COVID-19 in hospitalized adults who are receiving a systemic corticosteroid and require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Tocilizumab was previously available for this indication under an Emergency Use Authorization (EUA); it remains available under an EUA for treatment of children 2-17 years old who are hospitalized with COVID-19 and require oxygen support.

The package inserts of the GLP-1 receptor agonists dulaglutide (Trulicity), exenatide (Byetta, Bydureon BCise), liraglutide (Saxenda, Victoza), and semaglutide (Ozempic, Rybelsus, Wegovy) and the dual glucosedependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonist tirzepatide (Mounjaro, Zepbound) have been updated to include rare postmarketing reports of pulmonary aspiration associated with their use in patients undergoing elective surgery or other procedures requiring general anesthesia or deep sedation who had residual gastric contents despite preoperative...

Omlyclo (omalizumab-igec; Celltrion), a biosimilar product interchangeable with the recombinant anti-IgE monoclonal antibody Xolair, has been approved by the FDA for same indications as Xolair (see Table 1). Omlyclo is the first Xolair biosimilar to be approved in the US.

The FDA has approved mannitol powder for oral inhalation (Bronchitol – Chiesi) as add-on maintenance treatment to improve pulmonary function in adults with cystic fibrosis (CF). This product has been available in Europe for the same indication since 2012. Another formulation of mannitol inhalation powder (Aridol) is approved in the US for assessment of bronchial hyperresponsiveness.

In our article in issue 1687 on the updated 2023-2024 COVID-19 vaccines from Pfizer and Moderna (Med Lett Drugs Ther 2023; 65:161), the doses and formulations of the Pfizer vaccine were incorrect. A revised table has been posted in the online version of the article.

The FDA has approved Phexxi (Evofem), a nonhormonal prescription-only vaginal gel containing lactic acid, citric acid, and potassium bitartrate, for prevention of pregnancy. The gel is intended for on-demand contraception; it is not effective when used after intercourse. It was previously approved for use as a vaginal lubricant (Amphora), but was never marketed.

In our recent article on the combination of vanzacaftor, tezacaftor, and deutivacaftor (Alyftrek) for cystic fibrosis (Med Lett Drugs Ther 2025; 67:41), Table 3 misstated the formulations and dosage of the combination of elexacaftor, tezacaftor, and ivacaftor (Trikafta).

The FDA has approved Suflave (Sebela/Braintree), a low-volume polyethylene glycol (PEG)- and sulfate-based product for cleansing of the colon prior to colonoscopy in adults. Other oral colonoscopy preparations available in the US are listed in Table 2. Suflave is marketed as tasting better than other products.

Exagamglogene autotemcel (Casgevy – Vertex), a cell-based gene therapy recently approved for treatment of sickle cell disease1, has now been approved by the FDA for treatment of patients ≥12 years old with transfusion-dependent beta thalassemia. Casgevy is the first gene therapy that uses CRISPR/Cas9 gene-editing technology to be approved in the US for any disorder. Betibeglogene autotemcel (Zynteglo), an autologous lentiviral vector cell-based gene therapy, was approved in the US in 2022 for treatment of transfusion-dependent beta thalassemia.

The FDA has approved donislecel-jujn (Lantidra – CellTrans), an allogeneic pancreatic islet cellular therapy, for use in conjunction with immunosuppression for treatment of adults with type 1 diabetes who are unable to approach target HbA1c because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education. Donislecel is the first cell-based treatment to be approved in the US for type 1 diabetes.