Tag: regulatory compliance

CAMBRIDGE, Mass., June 18, 2025 (GLOBE NEWSWIRE) --  Biogen Inc. (Nasdaq: BIIB) announced the initiation of dosing in the BRAVE study, a global Phase 3 clinical trial. The BRAVE study will evaluate the efficacy and safety of omaveloxolone in children with Friedreich ataxia (FA) between the ages of 2 to <16. Both non-ambulatory and ambulatory participants may qualify for the study. Participants will be randomized 2:1 to receive omaveloxolone or placebo once a day for 52 weeks before having the opportunity to move into the open-label extension (OLE). Currently, omaveloxolone is commercialized under the brand name SKYCLARYS^® in over 40 countries, including in the U.S. and the European Union, and is the only approved product for FA in adults and adolescents aged 16 years and older.

CARDIFF, United Kingdom, June 17, 2025 (GLOBE NEWSWIRE) -- Llusern Scientific, a point-of-care diagnostics company, announces it has been awarded ISO 13485 certification for its Lodestar DX testing system, a rapid molecular diagnostic platform for urinary tract infections (UTIs). With industry-leading accuracy and speed, Lodestar DX empowers clinicians to diagnose and rule-out infections with precision in a single visit, thereby improving patient outcomes.

Operating legally in over 110 countries, VNBTC offers a compliant path to passive crypto income through Bitcoin and Dogecoin cloud mining.

Simplified capital structure bolsters ability to rapidly meet customer demand, reduce interest expense, and increase liquidity