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• Avoid common US import errors by vetting your filer, FDA says

  Providing accurate and complete information is critical when submitting an import entry to the US Food & Drug Administration (FDA) …

  

• Keytruda keys in on survival: Promising results in high-risk early-stage TNBC from KEYNOTE-522

  At the European Society for Medical Oncology Congress on September 13–17, promising results from the Phase III KEYNOTE-522 study involving …

  

• Merit Medical touts positive six-month data from WAVE trial

  Merit Medical has revealed positive six-month data from a trial investigating its endoprosthesis in dialysis patients who require an arteriovenous …

  

• FDA lifts partial clinical hold on Zentalis Pharma’s cancer WEE1 inhibitor  

  The US Food and Drug Administration (FDA) has lifted a partial clinical hold on Zentalis Pharmaceuticals’ azenosertib, allowing the company …

  

• FDA releases draft guidance on oncology multiregional clinical trials

  The US Food and Drug Administration (FDA) has released a new draft guidance on multiregional clinical trials (MRCTs) in oncology …

  

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