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European Commission (EC)

EC approves label update for Pfizer’s Xalkori in NSCLC

26 November 2015 | By Victoria White

The EC has approved a label update to expand the use of Xalkori (crizotinib) to first-line treatment of adults with ALK-positive NSCLC...

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EC approves anticoagulant reversal agent idarucizumab

26 November 2015 | By Victoria White

Idarucizumab (Praxbind) rapidly and specifically reverses the anticoagulant effects of dabigatran etexilate (Pradaxa) in cases of emergency surgery /urgent procedures or in uncontrolled bleeding...

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EC approves Cotellic plus Zelboraf in advanced melanoma

25 November 2015 | By Victoria White

The approval is based on data that showed Cotellic plus Zelboraf helped people with previously untreated BRAF V600 mutation-positive advanced melanoma live for more than a year without their disease worsening...

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EC grants marketing authorisation to Kyprolis in multiple myeloma

20 November 2015 | By Victoria White

The announcement makes Kyprolis (carfilzomib) the first irreversible proteasome inhibitor approved in the EU for use in combination treatment of patients with relapsed multiple myeloma.

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EC grants Marketing Authorisation for Obizur

13 November 2015 | By Victoria White

Obizur is the first recombinant porcine sequence FVIII treatment available in Europe to treat acquired haemophilia A...

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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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European Commission (EC)