The obesity drug’s new formulation gains an important opportunity to define the market before regulators finish assessing Lilly’s rival orforglipron. Novo Nordisk’s Wegovy (semaglutide) has become the first oral glucagon-like peptide 1 (GLP-1) receptor agonist to be available in the US for weight management.
2025 was a special year for EMA, its staff and the whole European Medicine Regulatory Network, as it marked three decades since the inception of the Agency, three decades of progress in science and medicines across the EU.
The FDA is inviting patient and consumer advocacy groups to participate in periodic consultation meetings on the reauthorization of the Biosimilar User Fee Act (BsUFA). BsUFA authorizes FDA to collect user fees from the regulated industry to support the process for the review of biosimilar biological products (biosimilars). The authorization for the current program (BsUFA …
On Dec. 23, 2025, the U.S. Food and Drug Administration approved Cablivi (caplacizumab-yhdp) for injection to treat pediatric patients 12 years and older with acquired thrombotic thrombocytopenic purpura (aTTP) in combination with plasma exchange and immunosuppressive therapy. Cablivi was originally approved in 2019 to treat adults with this condition.
Last week, the U.S. Food and Drug Administration (FDA) approved Yartemlea (narsoplimab-wuug) injection to treat adults and children 2 years and older with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) as the first approved treatment option for TA-TMA.
