RxNews®

October 24, 2025 - Syndax Pharmaceuticals announced the FDA approval of Revuforj (revumenib), for the treatment of relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options.

October 27, 2025 - Merck announced the FDA approval of an update to the indication for Winrevair (sotatercept-csrk), for the treatment of adults with pulmonary arterial hypertension (PAH, Group 1 pulmonary hypertension) to improve exercise capacity and World Health Organization (WHO) functional class, and reduce the risk of clinical worsening events including hospitalization for PAH, lung transplantation and death.

October 23, 2025 - GSK announced the FDA approval of Blenrep (belantamab mafodotin-blmf), in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.

October 22, 2025 - The FDA approved Meitheal Pharmaceuticals’ Contepo (fosfomycin), for the treatment of patients 18 years and older with complicated urinary tract infections (cUTI), including acute pyelonephritis, caused by susceptible isolates of Escherichia coli and Klebsiella pneumoniae.

October 24, 2025 - Azurity Pharmaceuticals announced the FDA approval of Javadin (clonidine), for the treatment of hypertension in adult patients, to lower blood pressure.

October 24, 2025 - Bayer announced the FDA approval of Lynkuet (elinzanetant), for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause.

October 17, 2025 - Merck announced a business decision to discontinue Zepatier (elbasvir/grazoprevir). Zepatier is not being discontinued for reasons of safety or effectiveness.

October 20, 2025 -  Ingenus Pharmaceuticals launched an AB-rated generic version of Pfizer’s Premarin (conjugated estrogens) tablets.