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  • 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.

  • The National Institute of Cholera and Enteric Diseases (NICED), a premier institute under the Indian Council of Medical Research (ICMR), is in talks with the West Bengal government to introduce a cholera vaccine ahead of the peak season as a preventive measure.

  • The Zika virus, spread by a day-biting mosquito and possibly linked to serious birth defects in Brazil, has the potential to spread within the Americas, including parts of the US, researchers have warned. The Zika virus, native to parts of Africa and Asia, has for the first time been introduced into the Americas where it is spreading locally among people who have not travelled abroad.

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