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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 …

FDA Requires Safety Labeling Changes for Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs) Due to Potential Increased Risk of Rare But Serious Eye Condition Read More »

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 …

FDA Request for Information — Patient-Level Data for RWD/RWE Submissions (Docket No. FDA-2026-N-10742) Read More »

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 »