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The good news is that the U.S. FDA’s complete response letter (CRL) for Venatorx Pharmaceuticals Inc.’s intravenous antibiotic combination, cefepime-taniborbactam, in complicated urinary tract infections (cUTIs) requested no additional clinical testing. The bad news is the inevitable delay for a drug Venatorx and partner Melinta Therapeutics Inc. are aiming to position as a much-needed option for the fight against drug-resistant gram-negative infections. ....
Zimmer Biomet Holdings Inc.’s Rosa robotics surgical assistant snapped up its fourth application with the U.S. FDA’s 510(k) clearance for use in shoulder replacement surgery. Over the past five years, the system has built a portfolio that includes partial and total knee replacement and total hip replacement. ....
THE Philippine Amusement and Gaming Corp. (Pagcor) sees a complete detachment from its casino operations and a shift to a purely regulatory function role within five years, its top official said on Friday. ....
Sky City Entertainment highlighted the regulatory and compliance issues facing the company when presenting a half-year result that showed a dip in statutory. ....