The agency’s new guidelines are created to eliminate pharmaceutical company practices that minimize or distract consumers ...
ALL patients who received Aucatzyl immunotherapy, made from their own T cells, experienced complete remission within three ...
PTC Therapeutics' gene therapy is already approved in the European Union, Great Britain, and Israel. The drugmaker will also ...
White & Case has hired the vice chair of DLA Piper's FDA regulatory practice, Bethany Hills, as a partner in its New York office. Hills will be part of White & Case's health care group and ...
Richard White, the founder-CEO of Australia's biggest ASX-listed tech company, WiseTech, is stepping down after 30 years in the role. WiseTech's global board said Mr White's departure was ...
Patient advocates hope Dr. Michelle Tarver will lead the agency to focus more on safety and less on rapid approvals. By Christina Jewett The Food and Drug Administration on Tuesday announced that ...
The company said it was not yet established that the vaccine had caused the safety event and it was working with the FDA to resolve the pause. "Our goal is to successfully resolve this matter and ...
As AI technology evolves rapidly, the FDA is tackling the challenge of balancing innovation with patient safety, shaping regulations that ensure AI tools remain effective throughout their entire ...
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