Stakeholders suggest things to be considered in developing tissue agnostic therapies.
FDA lifts a clinical hold against Solid Biosciences Phase 1/2 clinical trial for its investigational microdystrophin gene transfer, SGT-001, for treat...
FDA clears an Arcuro Medical 510(k) for its SuperBall meniscus repair system.
FDA issues a clinical hold on a Ziopharm Oncology Phase 1 trial to evaluate CD19-specific CAR-T therapies manufactured under point-of-care, and reques...
University of Ottawa law professor Amir Attaran suggests that the Canadian government should look at suspending U.S. drug patents as the Trump Adminis...
Federal Register notice: FDA establishes a public docket to receive information, recommendations, and comments on matters related to its publication o...
Federal Register notice: FDA announces an opportunity for public comment on an information collection extension for the agency guidance entitled Forma...
Federal Register notice: FDA has made available a draft guidance entitled Epidermolysis Bullosa (EB): Developing Drugs for Treatment of Cutaneous Mani...