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In one of the first demonstrations of the impact of last year’s Loper Supreme Court decision on challenges to agency authority, a judge ruled that the FDA does not have authority to regulate tests developed by clinical laboratories.

Johnson & Johnson, which did not apply for the national priority voucher, was granted the ticket based on results from a Phase III study testing Tecvayli plus Darzalex in patients with relapsed or refractory multiple myeloma.

Pattern Computer®, Inc. (“Pattern” or “the Company”) today announced the availability of the first paper produced by a research collaboration with Lawrence Berkeley National Laboratory (LBNL) and Los Alamos National Laboratory (LANL) and funded by the U.S. Department of Energy and the Defense Threat Reduction Agency (DTRA), which addresses the clear and critical need for pathogen agnostic diagnostics that can be quickly and effectively performed at point of need.