The European Commission has granted marketing authorisation to Stelara (ustekinumab) to treat patients aged six to 11 with moderate to severe plaque psoriasis.
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A novel formulation for dolutegravir has been developed to improve HIV treatment options for children. Dr Kimberly Smith from ViiV Healthcare discusses the benefits of this new dispersible tablet.
EU marketing authorisation has been given to Sunosi (solriamfetol) for excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnea.
The European Commission (EC) granted marketing authorisation for Darzalex in combination with bortezomib, thalidomide and dexamethasone (VTd) for multiple myeloma patients.
Marketing authorisation has been granted by the EC for Evenity® (romosozumab) to treat osteoporosis in postmenopausal women.
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.
The EC has released a report that has found generics and biosimilars decrease wasteful spending and maintain health quality in the EU.
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.