Johnson & Johnson (J&J) has secured marketing authorization from the US FDA for its Ottava robotic surgical system, allowing it to enter the soft-tissue robotic surgery market. The system, approved for several general surgery procedures, will initially launch with select US customers, challenging Intuitive Surgical's dominance.
US health advisers are reviewing Moderna's new mRNA flu vaccine, mFlusiva, for individuals 50 and older. The vaccine, similar to those used for COVID-19, showed a 27% reduction in flu cases in a study. The FDA is assessing its safety and efficacy, with a decision expected before the winter flu season.
UniQure plans to seek FDA accelerated approval for its Huntington's disease gene therapy, using three-year data from a Phase 1/2 study. This follows a recent FDA meeting that reversed previous criticisms of the evidence, with shares soaring 70%.
Wockhardt's novel antibiotic Zaynich (cefepime and zidebactam) has received US FDA approval for treating complicated urinary tract infections (UTIs), including pyelonephritis, caused by resistant microorganisms. It also gained approval in India for UTIs and concurrent Gram-negative bacteremia, addressing the growing antimicrobial resistance threat.
