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Panobinostat recommended by CHMP for EU approval to treat multiple myeloma
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...
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Committee for Medicinal Products for Human Use (CHMP)
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CHMP recommends granting marketing authorisation to Raxone for the treatment of Leber’s Hereditary Optic Neuropathy (LHON)
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...
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AVEO receives European regulatory guidance regarding potential marketing authorisation application for tivozanib
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...
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European Commission approves ALOXI injection to prevent nausea and vomiting due to chemotherapy in children as young as one month
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...
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CHMP recommends empagliflozin / metformin hydrochloride for approval in the EU for the treatment of Type 2 Diabetes
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...
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Amgen receives positive CHMP opinion for use of Vectibix® (panitumumab) as first-line treatment for advanced colorectal cancer
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)...
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Santen receives a positive CHMP opinion for EU marketing authorization for Ikervis®
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®...
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Novartis drug Jakavi® recommended by CHMP for EU approval to treat adults with rare blood cancer polycythemia vera
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...
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European Commission approves Rezolsta, a new once-daily, fixed-dose HIV therapy combining darunavir and cobicistat
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...
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CHMP recommends label update for Esbriet in idiopathic pulmonary fibrosis, strengthening mortality benefit and reinforcing safety profile
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...
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Almirall’s aclidinium bromide/formoterol fumarate recommended for approval in Europe to treat COPD
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...
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CHMP issues positive opinion for intravenous formulation of Merck’s NOXAFIL® (posaconazole)
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)...
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Xultophy® (IDegLira) receives positive opinion from the Committee for Medicinal Products for Human Use for use in adults with type 2 diabetes
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®...
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CHMP recommends EU approval of Roche’s Avastin for platinum-resistant recurrent ovarian cancer
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)...
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CHMP adopts positive opinion for plegridytm (peginterferon beta-1a) as a treatment for multiple sclerosis in the European Union
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...
