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EC expands Takeda’s Adcetris authorisation for Hodgkin lymphoma
pharmaceutical-technology
February 14, 2019
The European Commission (EC) has expanded the marketing authorisation of Takeda Pharmaceutical’s Adcetris (brentuximab vedotin) to adults with previously untreated CD30+ Stage IV Hodgkin lymphoma....
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EC approves Vertex’s Orkambi for children with cystic fibrosis
pharmaceutical-technology
January 23, 2019
Vertex Pharmaceuticals has received approval from the European Commission (EC) to expand the indication of its Orkambi to treat paediatric patients suffering from cystic fibrosis (CF)....
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European Commission approves Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) for first-line treatment of patients with intermediate- and poor-risk advanced renal cell carcinoma
worldpharmanews
January 17, 2019
This decision represents the first approval of an Immuno-Oncology (I-O) combination therapy for patients with this type of cancer in the European Union.
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Novartis receives European Commission approval for self-administration of Xolair® across all indications
en-cphi.cn
December 14, 2018
Novartis today announced that the European Commission (EC) has approved Xolair® (omalizumab) prefilled syringe (PFS) for self-administration, allowing patients with severe allergic asthma (SAA) and chronic spontaneous urticaria (CSU) to administer their o
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Novartis Receives EC Approval for Self-Administration of Xolair across all Indications
americanpharmaceuticalreview
December 14, 2018
Novartis announced that the European Commission (EC) has approved Xolair (omalizumab) prefilled syringe (PFS) for self-administration.....
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EC approves self-administration of Novartis’ Xolair
pharmaceutical-technology
December 14, 2018
The European Commission (EC) has approved the prefilled syringe (PFS) of Novartis’ Xolair (omalizumab) medication for self-administration by patients with ......
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EC Approves Takeda’s ALUNBRIG for ALK+ Non-Small Cell Lung Cancer
biospectrumasia
December 03, 2018
“The European Commission’s decision to approve ALUNBRIG for patients with ALK+ NSCLC is a significant advancement for European patients impacted by this life-threatening disease”
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Merck secures EC approval for Delstrigo and Pifeltro indications
pharmaceutical-technology
November 30, 2018
The European Commission has granted approval to Merck for its indications Delstrigo and Pifeltro to treat adults with HIV-1.Delstrigo is a new once-daily......
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EC approves Sandoz’s biosimilar Ziextenzo for febrile neutropenia
pharmaceutical
November 29, 2018
Novartis unit Sandoz has received marketing authorisation from the European Commission (EC) for biosimilar Ziextenzo (pegfilgrastim).......
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Sandoz Receives Eighth EC Approval for Biosimilar with Ziextenzo
americanpharmaceuticalreview
November 28, 2018
Sandoz announced that the European Commission (EC) granted marketing authorization for biosimilar Ziextenzo (pegfilgrastim).Ziextenzo is indicated to reduce the duration......