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European Commission (EC)

EC approves Zalviso for post-operative pain

22 September 2015 | By Victoria White

Zalviso is designed to offer sustained (for up to 72 hours) pain relief for acute moderate-to-severe post-operative pain...

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EC approves Shire’s ADHD treatment Intuniv

21 September 2015 | By Victoria White

The EC has granted Marketing Authorisation for Intuniv for the treatment of ADHD in children and adolescents for whom stimulants are not suitable...

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EC grants marketing authorisation for Raxone in Leber’s Hereditary Optic Neuropathy

9 September 2015 | By Victoria White

Raxone is the first approved treatment for Leber’s Hereditary Optic Neuropathy, and for a mitochondrial disease, in the EU...

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EC approves Odomzo for basal cell carcinoma

20 August 2015 | By Victoria White

The EC has approved Novartis’ Odomzo (sonidegib) 200 mg capsules for the treatment of adult patients with locally advanced basal cell carcinoma...

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EC grants Marketing Authorisation for dinutuximab

17 August 2015 | By Victoria White

The EC has granted Marketing Authorisation for dinutuximab for the treatment of high-risk neuroblastoma in patients aged 12 months to 17 years...

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EC grants Orphan Drug Designation to SGX301

4 August 2015 | By Victoria White

The EC has granted orphan drug designation to Solgenix’s synthetic hypericin (the active ingredient in SGX301) for the treatment of cutaneous T-cell lymphoma...

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EC approves Keytruda for the treatment of melanoma

23 July 2015 | By Victoria White

The EC has approved Merck’s Keytruda (pembrolizumab) for the treatment of advanced (unresectable or metastatic) melanoma in adults...

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Janssen’s ibrutinib approved by the EC for the treatment of Waldenström’s macroglobulinemia

10 July 2015 | By Victoria White

Janssen-Cilag International announced today that the European Commission (EC) has approved Imbruvica® (ibrutinib) capsules as a treatment option for adult patients with Waldenström’s macroglobulinemia (WM).

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European Commission approves Orfadin oral suspension

29 June 2015 | By Victoria White

The European Commission (EC) has approved the oral suspension formulation of Sobi’s Orfadin for the treatment of Hereditary Tyrosinaemia type-1 (HT-1)...

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EC approves Opdivo for the treatment of advanced melanoma patients

22 June 2015 | By Victoria White

The European Commission has approved Bristol-Myers Squibb’s Opdivo, a PD-1 immune checkpoint inhibitor, for the treatment of advanced melanoma in adults...

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UMC Utrecht’s new liver cancer treatment approved for use in Europe

14 April 2015 | By Victoria White

A new liver cancer treatment developed by the UMC Utrecht that uses uses radioactive holmium microspheres has received the European CE mark...

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MODHEP film debuts at European Parliament

1 April 2015 | By Victoria White

"MODHEP: Understanding liver cancer" shown at European Parliament to delegates at an event celebrating collaboration between the EU and other countries...

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Saxenda approved in Europe for the treatment of obesity

24 March 2015 | By Victoria White

Novo Nordisk has announced that the European Commission has granted marketing authorisation for Saxenda ® (liraglutide 3 mg) for the treatment of obesity...

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European Commission approves additional indication for VELCADE® (bortezomib) in mantle cell lymphoma

6 February 2015 | By Janssen EMEA

Janssen-Cilag International NV (Janssen) announced today that the European Commission has approved a variation to the terms of the marketing authorisation of VELCADE® (bortezomib) in combination with rituximab, cyclophosphamide, doxorubicin and prednisone for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are unsuitable for blood…

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Once daily treatment option made available for up to one million adult Britons with type 2 diabetes and moderate chronic kidney disease

21 January 2015 | By Aurora

A once daily injection has been approved for adults with type 2 diabetes and moderate renal impairment (stage 3 chronic kidney disease) in the UK...

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European Commission (EC)