Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Tandem, Venus Concept.
UNESCO has adopted the first set of global standards on the ethics of neurotechnology amid the rapid advancement in the development of the technologies and increasing investor interest. These standards, which take effect on Nov. 12, 2025, establish safeguards to ensure that neurotechnology improves the lives of those who need it the most without compromising human rights.
The U.K. Medicines and Healthcare Products Regulatory Agency has laid out an approach to medical products for rare diseases, which the agency said afflict 3.5 million U.K. citizens. One of the objectives of this program is to simplify evidence requirements for these therapies with the hope of providing patients with more rapid access to much-needed therapeutic options.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Castle Biosciences, EBR Systems, Laborie Medical, Lunit, Organon, Scibase.
Aussie radiopharma company Advancell Co. Ltd. unveiled promising early clinical data that could redefine how advanced prostate cancer is treated by targeted alpha therapies in the radiopharmaceutical space.
Despite the formidable challenges for developing precision psychiatry, the approach is notching its first successes in the preclinical and even some clinical settings. Many individual studies as well as large projects like the Psychiatric Ratings using Intermediate Markers studies and the Psychiatric Biomarkers Network have been looking at multiple biomarker types, and have begun to identify predictors of specific symptoms, or disease progression.
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