EMA publishes agenda for 25-29 January CHMP meeting

25 January 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...

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Mirum Pharmaceuticals broadens Expanded Access Program for maralixibat in Alagille syndrome to Europe and Australia

5 November 2020 - Maralixibat Expanded Access Program now available for patients with pruritus associated with Alagille syndrome in Australia and ...

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Forxiga approved in Europe for type 1 diabetes mellitus

25 March 2019 - Forxiga is the first oral medicine approved in Europe as an adjunct to insulin for adults ...

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Mylan and Biocon receive approvals from the European Commission and TGA Australia for Semglee, biosimilar insulin glargine

27 March 2018 - Mylan and Biocon today announced that their co-developed biosimilar insulin glargine Semglee has received marketing authorisation ...

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