EMA has recommended extending the use of Gazyvaro (obinutuzumab) in the European Union to treat adults with moderate to severe, active systemic lupus erythematosus (SLE). The medicine will be used as an add-on treatment in patients who test positive for certain antibodies and whose disease remains active despite standard therapy.
On November 13, 2026, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) in combination with enfortumab vedotin-ejfv as neoadjuvant treatment, followed by single agent durvalumab as adjuvant treatment after radical cystectomy, for the treatment of adult patients with muscle invasive bladder cancer (MIBC) who are ineligible for or who have refused cisplatin based chemotherapy.
The U.S. Food and Drug Administration is informing patients and health care providers of a potential increased risk of non-arteritic anterior ischemic optic neuropathy (NAION) associated with use of glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications. NAION is a rare condition that can result in acute, painless, decreased vision in one eye, including permanent vision …
On November 10, 2026, the Food and Drug Administration approved pimicotinib (Pimjetmi, EMD Serono, Inc.), a kinase inhibitor, for adults with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection may cause worsening functional limitation or severe morbidity.
The U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are aware of challenges sponsors encounter in submitting patient-level data for real-world data (RWD) analyzed as part of clinical studies in a marketing application. These challenges relate to data ownership, privacy requirements (including …
EMA’s Emergency Task Force (ETF) and the African Medicines Agency (AMA) have published a joint position paper to support the timely start of clinical trials for potential vaccines against Ebola disease caused by Bundibugyo virus (BDBV). The paper was developed following a scientific consultation with relevant experts, hosted by AMA, EMA and the World Health …
AMA and EMA issue joint guidance on Ebola vaccine development Read More »
In the FDA’s latest From a Global Perspective, Marta Sokolowska from the FDA and Steffen Thirstrup from the European Medicines Agency (EMA) provide their “Regulatory Perspectives on Herbal Medicinal / Botanical Drug Development.” This conversation between leaders of each agency focused on the recent FDA/EMA workshop on this topic and how the regulators are working …
FDA and EMA Discussion on Herbal & Botanical Drug Products Read More »
