Eli Lilly has asked the European Medicines Agency to grant accelerated assessment to its planned EU marketing application for pirtobrutinib. Meanwhile, the agency has rejected requests to fast-track SIFI’s Akantior and Janssen’s Zejula plus Zytiga combination therapy. 

Among the highlights of MedTech Europe’s annual MedTech Forum are the “unfiltered” views offered by company CEOs on the entire range of issues that influence decision-making or will have an impact on business operations in the near term.

The Roivant-owned company's Vtama topical cream was approved by the US FDA with a broad label permitting use for mild, moderate or severe psoriasis.

While industry concern with FDA’s policy shift on clinical data from China has focused on the disruption in business plans, Republican lawmakers appear to feel that the agency has not gone far enough and are seeking a GAO review of FDA’s entire bioresearch monitoring program.