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4 June 2015 | By Victoria White
AVEO has received confirmation of support from two CHMP members following pre-submission meetings to discuss the potential submission of a MAA for tivozanib...
27 May 2015 | By Victoria White
Helsinn Group has announced that the European Commission has approved ALOXI injection for the prevention of acute CINV in children aged one to six months...
30 March 2015 | By Victoria White
BI and Lilly announce they have received a positive opinion from CHMP, recommending empagliflozin/metformin hydrochloride for the treatment type 2 diabetes...
2 March 2015 | By Amgen
Amgen announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion to extend the marketing authorization for Vectibix® (panitumumab) to include combination with FOLFIRI (an irinotecan-based chemotherapy) as first-line treatment in adult patients with wild-type RAS metastatic colorectal cancer (mCRC)...
26 January 2015 | By NewCap.
Santen SAS announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending the granting of a marketing authorization for Ikervis®...
23 January 2015 | By Novartis
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Jakavi® (ruxolitinib) for the treatment of adult patients with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea...
25 November 2014 | By Janssen
Janssen-Cilag International NV announced that the European Commission (EC) has approved the use of REZOLSTA® (darunavir/cobicistat) in combination with other antiretroviral (ARV) medicinal products for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years or older...
27 October 2014 | By Roche
Roche announced that Esbriet® (pirfenidone) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for an update to its European prescribing information, strengthening the efficacy claims and supporting the well-established safety profile based on the additional data from the phase III ASCEND trial...
26 September 2014 | By Almirall S.A
Almirall S.A. announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion for the regulatory approval of Duaklir® Genuair® (aclidinium bromide/formoterol fumarate) in all EU member states...
30 July 2014 | By Merck
Merck announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of a new, investigational intravenous formulation of NOXAFIL® (posaconazole)...
29 July 2014 | By Novo Nordisk
Novo Nordisk announced that the Committee for Medicinal Products for Human Use under the European Medicines Agency has adopted a positive opinion for Xultophy®...
27 June 2014 | By Roche
Roche announced that the EU Committee for Medicinal Products for Human Use recommended that the European Commission approve the use of Avastin® (bevacizumab)...
30 May 2014 | By Biogen Idec
Biogen Idec received a positive recommendation from the Committee for Medicinal Products for Human Use of the European Medicines Agency for the marketing authorisation of PLEGRIDY...
23 May 2014 | By Roche
Roche announced that the EU Committee for Medicinal Products for Human Use recommended that the European Commission approve Gazyvaro in combination with chlorambucil for the treatment of adult patients with previously untreated chronic lymphocytic leukemia...
24 March 2014 | By The European Medicines Agency
The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the granting of a marketing authorisation for Sylvant (siltuximab)...
