Moderna and Merck shares soared on Wednesday after the companies said a personalized mRNA treatment hit its target of preventing skin cancer from recurring or spreading in a late-stage clinical trial.
Why it matters: The results come at a pivotal moment for Moderna and mRNA research, after Trump administration health officials cut federal funding for new vaccines and asserted the technology poses more risks than rewards.
President Trump announced Wednesday he's nominating White House aide Heidi Overton to lead the Food and Drug Administration.
Why it matters: The agency was left in turmoil after the exit of former commissioner Marty Makary earlier this year, threatening the stability of U.S. drug development.
The American Medical Association is out with a new framework for physicians' role in the age of AI, provided first to Axios, that insists doctors remain central to patient care.
Why it matters: The debate over whether AI will supplant doctors in clinical care is heating up, but the AMA has remained adamant that humans not only must remain in the loop but can't be replaced.
The Trump administration's push to reshore drug development is becoming part of efforts to renew the user fee system that pays for review of new medicines.
Why it matters: "America First" incentives the administration is proposing would add a political twist to what's been a bipartisan process, but could gain favor as policymakers look for ways to reduce dependence on China.
The Food and Drug Administration is considering evaluating generative AI-enabled medical devices through a "competency-based approach," similar to how doctors are evaluated, the agency writes in a discussion paper first shared with Axios.
Why it matters: Emerging medical technologies are challenging the existing framework for overseeing medical devices, prompting calls for new approaches.
