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Imbruvica® granted expanded use from European Commission
The European Commission has approved the drug for two indications: chronic lymphocytic leukaemia and Waldenström's macroglobulinemia.
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European Commission (EC)
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Clinical trial sponsors called to publish results on EU database
All sponsors of clinical trials conducted in the European Union have been reminded of their obligation to make summaries of trial results.
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Lynparza has been approved for BRCA-mutated advanced ovarian cancer
BRCA-mutated advanced ovarian cancer treatment has been approved by the European Commission.
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Public consultation on key principles for ePI of EU medicines
The European Medicine Agency has launched a six month consultation on the principles that will form the basis of the electronic product information (ePI)...
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EMA surveys pharma companies on their preparedness for Brexit
The EMA is launching a survey to gather information from companies on their Brexit preparedness plans and identify any particular concerns with regard to medicines supply that may impact public or animal health...
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EC grants orphan drug designation for Gilteritinib for the treatment of AML
The European Commission has issued Orphan Designation to gilteritinib for the treatment of patients with acute myeloid leukaemia...
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FDA accepts IND for the treatment of mucopolysaccharidosis type IIIA
The FDA has issued a Study may proceed letter for the first study in humans, thereby accepting the investigational new drug application for the drug candidate SOBI003...
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EC approves first biosimilar Mvasi for the treatment of cancer
The European Commission has granted marketing authorisation for Mvasi for the treatment of certain types of cancer...
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European Commission approves ocrelizumab for RMS and PPMS
Ocrelizumab provides a new treatment option for adults with active relapsing forms of multiple sclerosis...
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EC extends license for Zytiga to treat early stage prostate cancer
The EC has granted approval to broaden the existing marketing authorisation for Zytiga to include early stage metastatic prostate cancer...
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Methodology developed for assessing the value of new medicines
The Advance Value Framework has addressed the pitfalls of current approaches assessing the value of new medicines...
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Novartis combination targeted therapy receives FDA approval
The FDA has approved Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) to treat patients with metastatic non-small cell lung cancer.
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Sandoz receives EU approval in Europe for Rixathon (biosimilar rituximab)
The EC has approved Sandoz’ Rixathon (biosimilar rituximab) for use in Europe. Rixathon is approved for use in all indications of the reference medicine...
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Sandoz receives EU approval for Erelzi (biosimilar etanercept)
The European Commission (EC) has approved Sandoz’ (a Novartis division) Erelzi (biosimilar etanercept) for use in Europe, to treat inflammatory diseases...
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EU approval for Regeneron and Sanofi’s rheumatoid arthritis drug
The European Commission (EC) has granted marketing authorisation for Regeneron and Sanofi’s Kevzara (sarilumab) for the treatment of rheumatoid arthritis...
