Shots: The FDA has approved Nulibry based on three clinical trials compared to data from a natural history study in patients with MoCD Type A The results from three clinical trials showed improvement in overall survival and an 82% reduction in the risk of death, @3yrs. probability of survival in rcPMP-treated patients (84% vs 55%), […]Read More
Shots: The NDA is based on P-III VICTORIA study assessing vericiguat (qd, (titrated up to 10mg) vs PBO when given in combination with available HF therapies in ~5,050 patients with worsening CHF, reduced left VEF of <45% within 12mos. prior to randomization following a decompensation event The 1EPs is the composite of time to the […]Read More
Shots: The US FDA approved Roche’s cobas HPV test for use on cobas 6800/8800 systems that enable molecular laboratories to achieve the efficiency and scale needed for meeting the demands of high-volume cervical screening programs The approval is based on IMPACT study assessing cobas HPV test in ~ 35,000 women to clinically validate the test […]Read More
Shots: The approval is based on P-III SHIFT study trial assessing Corlanor vs PBO +SoC in 6500+ patients with reduced left ventricular function (LVEF ≤35%) and heart rate ≥70 bpm, hospitalization for heart failure within the past 12 months The P-III study resulted in reduction in risk of primary composite endpoint of hospitalization or cardiovascular […]Read More
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