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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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.
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.
XospataTM (gilteritinib) has been approved as a monotherapy for patients with relapsed or refractory acute myeloid leukaemia with a FLT3 mutation.
The cannabidiol-based treatment EPIDYOLEX has been granted marketing authorisation from the European Commission.
The biologic treatment ustekinumab has been granted an expanded use for ulcerative colitis within the EU.
A new biosimilar drug to treat osteoporosis is now available across Europe after the patent for its reference product expired.
The European Commission has approved the drug for two indications: chronic lymphocytic leukaemia and Waldenström's macroglobulinemia.
All sponsors of clinical trials conducted in the European Union have been reminded of their obligation to make summaries of trial results.
BRCA-mutated advanced ovarian cancer treatment has been approved by the European Commission.
The European Medicine Agency has launched a six month consultation on the principles that will form the basis of the electronic product information (ePI)...
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...
The European Commission has issued Orphan Designation to gilteritinib for the treatment of patients with acute myeloid leukaemia...
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...
The European Commission has granted marketing authorisation for Mvasi for the treatment of certain types of cancer...