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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...
26 June 2015 | By Victoria White
The CHMP of the EMA have adopted a positive opinion for panobinostat capsules for the treatment of patients with multiple myeloma...
26 June 2015 | By Victoria White
CHMP has recommended granting marketing authorisation to Raxone for the treatment of visual impairment in patients with Leber's Hereditary Optic Neuropathy...
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®...
