Genmab announces European regulatory submission for daratumumab in combination with lenalidomide and dexamethasone in frontline multiple myeloma

22 March 2019 - Type II variation application submitted to the EMA for daratumumab in combination with lenalidomide and dexamethasone as ...

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Boehringer Ingelheim announces FDA and EMA regulatory submission for nintedanib in systemic sclerosis associated ILD

18 March 2019 - Systemic sclerosis, also known as scleroderma, is a rare chronic connective tissue disease. ...

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Praluent (alirocumab) now approved in European Union to reduce the risk of cardiovascular events in patients with established cardiovascular disease

15 March 2019 - Approval is based on ODYSSEY OUTCOMES trial of 18,924 patients who recently suffered an acute coronary syndrome ...

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European Commission approves Roche’s MabThera (rituximab) for a rare auto-immune disease

15 March 2019 - MabThera is now approved in Europe to treat four auto-immune diseases. ...

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An EU wide approach to HTA: an irrelevant development or an opportunity not to be missed?

14 March 2019 - An EU-wide cooperation on HTA has been proposed recently by the European Commission, focusing on relative effectiveness ...

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European Commission approves Merck’s Keytruda (pembrolizumab) in combination with chemotherapy for first-line treatment of adults with metastatic squamous non-small cell lung cancer

14 March 2019 - European approval based on KEYNOTE-407 study results demonstrating significant improvement in overall survival with Keytruda in combination ...

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European Commission approves Roche’s Hemlibra for people with severe haemophilia A without factor VIII inhibitors

14 March 2019 - First medicine to significantly reduce treated bleeds compared to prior factor VIII prophylaxis, in a prospective intra-patient ...

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Advicenne announces submission of European marketing authorisation application for ADV7103 as treatment for distal renal tubular acidosis

12 March 2019 - Advicenne announces today that it has submitted a marketing authorisation application to tEMA for its lead ...

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EMA now operating from Amsterdam

11 March 2019 - As of today, EMA is operating from Amsterdam.  ...

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Celgene submits application to EMA for ozanimod for the treatment of relapsing-remitting multiple sclerosis

11 March 2019 - New drug application submission to U.S. FDA on track for end of March. ...

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European Medicines Agency validates application for Bavencio (avelumab) plus Inlyta (axitinib) for the treatment of advanced renal cell carcinoma

8 March 2019 - Merck and Pfizer today announced that the EMA has validated for review the Type II variation ...

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Samsung Bioepis gains approval to sell bigger size Ontruzant in Europe

5 March 2019 - Samsung Bioepis has gained approval to sell bigger-size Ontruzant in Europe, the company said Tuesday. ...

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European Medicines Agency adopts positive opinion for Merck’s Keytruda (pembrolizumab) for six-week dosing schedule across all current monotherapy indications

4 March 2019 - Merck today announced that the CHMP of the EMA has recommended the approval of a new ...

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Regulatory information – adjusted fees for applications to EMA from 1 April 2019

1 March 2019 - The EMA reminds applicants and marketing authorisation holders that adjusted fees for all applications, except for ...

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Novo Nordisk files for a label update for Fiasp to the EMA and the FDA seeking approval for use in children and adolescents

1 March 2019 - Novo Nordisk today announced that it has submitted label updates to the EMA and the US FDA ...

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