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Clinical courses

 

Clinical courses

  • The US Food and Drug Administration cleared the Olympus TJF-Q180V duodenoscope with modifications to the device’s design and labeling intended to help reduce the risk of bacterial infections. Olympus will voluntarily recall its original model currently being used in health care facilities and make the needed repair as quickly as possible.

  • Heron Therapeutics, Inc., announced that the U.S. Food and Drug Administration (FDA) has informed the Company that it has not yet completed its review of the New Drug Application (NDA) of SUSTOL® (granisetron) Injection,extended release and would not be taking action by the Prescription Drug User Fee Act (PDUFA) goal date of January 17, 2016 and anticipates taking action in late February 2016.

  • Nivalis Therapeutics, Inc., a clinical stage pharmaceutical company focused on developing innovative solutions for people with cystic fibrosis (“CF”),  announced the U.S. Food and Drug Administration ("FDA") has granted Orphan Drug Designation to the Company's lead investigational drug, N91115, a novel stabilizer of the cystic fibrosis transmembrane conductance regulator (CFTR) protein.

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