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EC approves expanded indication for cystic fibrosis treatment
The European Commission has approved the label extension for KALYDECO® (ivacaftor) to include the treatment of infants with cystic fibrosis between six and 12 months old.
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European Commission (EC)
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Generics and biosimilars vital to reduce healthcare costs, finds EC
The EC has released a report that has found generics and biosimilars decrease wasteful spending and maintain health quality in the EU.
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EU marketing authorisation granted for rheumatoid arthritis treatment
Remsima SC™ is the world’s first subcutaneous formulation of infliximab and has been approved in the EU for the treatment of people with rheumatoid arthritis.
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EC approves two new regimens of Keytruda for HNSCC
The European Commission has given its approval to Keytruda to treat head and neck squamous cell carcinoma as a monotherapy or in combination with a chemotherapy.
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AML gilteritinib treatment approved by the European Commission
XospataTM (gilteritinib) has been approved as a monotherapy for patients with relapsed or refractory acute myeloid leukaemia with a FLT3 mutation.
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EPIDYOLEX® receives marketing authorisation in Europe
The cannabidiol-based treatment EPIDYOLEX has been granted marketing authorisation from the European Commission.
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EC approves expanded use of ustekinumab for ulcerative colitis
The biologic treatment ustekinumab has been granted an expanded use for ulcerative colitis within the EU.
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Terrosa® osteoporosis biosimilar treatment launched in Europe
A new biosimilar drug to treat osteoporosis is now available across Europe after the patent for its reference product expired.
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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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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...
