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22 January 2016 | By Victoria White
The EC has approved the Type II variation for Adcetris to include data on the retreatment of adult patients with R/R Hodgkin lymphoma or R/R sALCL who previously responded to Adcetris and who later relapse....
22 January 2016 | By Victoria White
The decision includes an update of the product information of all ambroxol and bromhexine containing products to include the rare risk of hypersensitivity reactions and a Precaution and Warning regarding severe cutaneous adverse reactions...
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...
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...
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...
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.
13 November 2015 | By Victoria White
Obizur is the first recombinant porcine sequence FVIII treatment available in Europe to treat acquired haemophilia A...
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...
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...
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...
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...
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...
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...
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...
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).
