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25 September 2015 | By Victoria White
The CHMP’s recommendation is based primarily on results of a Phase III study that showed that people who received the combination of Cotellic and Zelboraf lived over a year without their disease worsening...
25 September 2015 | By Victoria White
The CHMP’s recommendation will now be reviewed by the European Commission. If approved, Genvoya would be Gilead’s first single tablet regimen to contain TAF...
25 September 2015 | By Victoria White
Idarucizumab is intended for use in patients treated with dabigatran who require immediate anticoagulant reversal prior to urgent procedures or in case of uncontrolled bleeding...
25 September 2015 | By Victoria White
The CHMP adopted a positive opinion for an expanded indication of azacitidine for the treatment of adult patients aged 65 years or older with acute myeloid leukaemia who are not eligible for haematopoietic stem cell transplantation...
25 September 2015 | By Victoria White
The CHMP has adopted a positive opinion for Novartis’ Entresto (sacubitril/valsartan), marking an important milestone towards the drug becoming available in the EU.
30 July 2015 | By Victoria White
CHMP has granted a label extension for Synflorix to include protection against IPD caused by pneumococcal serotype 19A in children aged 6 weeks to 5 years...
28 July 2015 | By Victoria White
The CHMP has adopted a positive opinion for the marketing authorisation of Obizur for the treatment of bleeding episodes in patients with haemophilia...
27 July 2015 | By Victoria White
CHMP has adopted a positive opinion for Revolade for the treatment of patients with severe aplastic anaemia who have had an insufficient response to IST...
27 July 2015 | By Victoria White
CHMP has adopted a positive opinion recommending the approval of isavuconazole for the treatment of invasive aspergillosis and mucormycosis...
24 July 2015 | By Victoria White
The CHMP has adopted a positive opinion for on marketing authorisation of Fexeric, recommending its approval for the treatment of hyperphosphatemia in CKD...
24 July 2015 | By Victoria White
The CHMP has adopted a positive opinion recommending the approval of Shire’s Intuniv for the treatment of ADHD in children and adolescents...
29 June 2015 | By Victoria White
The Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation in the EU for CSL Behring's Respreeza...
29 June 2015 | By Victoria White
The CHMP has recommended that the EC approves the use of Perjeta for the neoadjuvant treatment of adult patients with HER2-positive early breast cancer...
29 June 2015 | By Victoria White
The CHMP has issued a positive opinion for the expanded use of Novo Nordisk’s Levemir (insulin detemir) in children with diabetes as young as one year old...
26 June 2015 | By Victoria White
Alexion has announced that the CHMP of the EMA has adopted positive opinions recommending marketing authorisation of Strensiq and Kanuma...
