FDA Panel Set to Review GRAIL Multi-Cancer Blood Test
The FDA is preparing to review GRAIL’s Galleri multi-cancer blood test, a technology designed to detect signals from many cancers through one blood sample soon.
FDA
FDA Seeks Feedback on Generative AI Medical Device Regulation
FDA is seeking public feedback on regulating generative AI-enabled medical devices while balancing innovation, clinical evidence, cybersecurity, and patient safety for doctors and patients nationwide.
uniQure Seeks U.S. Approval for Experimental Huntington Gene Therapy
Biotech company uniQure has applied for U.S. approval of an experimental Huntington’s gene therapy after FDA reversed an earlier position on its development this year.
FDA Adds Boxed Warning Over Injectafer Low Phosphate Risk
FDA added a boxed warning to Injectafer labeling over low blood phosphate risks, advising monitoring for patients receiving repeat courses or facing risk factors closely.