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Xeris Pharmaceuticals, Inc.: Xeris Pharmaceuticals Receives U.K. MHRA Approval of Ogluo (glucagon) Injection for the Treatment of Severe Hypoglycaemia in Adults, Adolescents, and Children Aged 2 Years and Over With Diabetes Mellitus


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Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced that the United Kingdom s Medicines and Healthcare Regulatory Agency (MHRA) has approved Ogluo (glucagon) injection for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus.
In February, the European Commission (EC) approved Ogluo. As the EC decision was received after the end of the Brexit transition period, Xeris was required to complete a further administrative step in order to obtain a license in Great Britain. No re-examination of clinical data by MHRA was required. The marketing authorization is valid in the United Kingdom, all 27 countries of the European Union, Iceland, Norway, and Liechtenstein. ....

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Xeris Pharmaceuticals Receives European Commission Approval of Ogluo (glucagon) Injection for the Treatment of Severe Hypoglycaemia in Adults, Adolescents, and Children Aged 2 Years and Over With Diabetes Mellitus


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Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced that the European Commission (EC) has approved Ogluo™ (glucagon) injection for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus. The marketing authorisation is valid in all 27 countries of the European Union, plus Iceland, Norway, and Liechtenstein. As the EC decision was received after the end of the Brexit transition period, Xeris will complete a further administrative step in order to obtain a license in Great Britain. No re-examination of clinical data by the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) is expected. ....

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