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EC Grants Orphan Designation to Sparsentan for IgA Nephropathy
americanpharmaceuticalreview
February 24, 2021
Travere Therapeutics announced the European Commission (EC) has granted orphan designation to sparsentan for the treatment of IgA nephropathy (IgAN), a rare kidney disorder and a leading cause of end-stage kidney disease (ESKD).
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Xeris Receives European Commission Approval of Ogluo for Hypoglycemia
americanpharmaceuticalreview
February 22, 2021
Xeris Pharmaceuticals announced the European Commission (EC) has approved Ogluo™ (glucagon) injection for the treatment of severe hypoglycemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus.
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EC buys additional 150 mn doses of Moderna’s COVID-19 vaccine
expresspharma
February 18, 2021
Moderna announced that the European Commission purchased an additional 150 million doses of the COVID-19 Vaccine Moderna, which are scheduled to be delivered in the third and fourth quarter of 2021.
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European Commission approves dispersible tablets to treat paediatric HIV
europeanpharmaceuticalreview
January 14, 2021
Marketing authorisation in the EU has been given to Tivicay (dolutegravir) dispersible tablets to treat HIV in certain paediatric patients.
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European Commission approves first treatment for peanut allergy
europeanpharmaceuticalreview
January 06, 2021
Aimmune Therapeutics’ PALFORZIA® has been approved by the European Commission as a treatment for peanut allergy.
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Roche gets EC nod for Phesgo to treat HER2-positive breast cancer
pharmaceutical-business-review
December 30, 2020
Roche has secured approval from the European Commission (EC) for its Phesgo to treat early and metastatic HER2-positive breast cancer.
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EU green light for Zogenix’s Fintepla
pharmatimes
December 24, 2020
The European Commission (EC) has approved Zogenix’s Fintepla (fenfluramine) for the treatment of seizures associated with Dravet syndrome.
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EC orders additional 80 million doses of Moderna’s COVID-19 vaccine
europeanpharmaceuticalreview
December 22, 2020
Europe will receive an extra 80 million doses of Moderna’s mRNA-1273, a COVID-19 vaccine candidate, following the EC’s decision.
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Aimmune’s peanut allergy med Palforzia wins EU approval
pharmatimes
December 22, 2020
The European Commission (EC) has approved Aimmune Therapeutics’ Palforzia, making it the first treatment for peanut allergy in the EU, according to the firm.
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Acceleron gets EC orphan designation for sotatercept to treat PAH
pharmaceutical-business-review
December 17, 2020
Acceleron Pharma has secured orphan designation from the European Commission (EC) for its sotatercept to treat patients with pulmonary arterial hypertension (PAH).