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19 February 2016 | By Victoria White
In combination with the current standard of care, Zurampic provides a dual mechanism of action to increase excretion and decrease production of uric acid...
3 February 2016 | By Victoria White
The European Commission (EC) has granted conditional marketing authorisation for AstraZeneca's Tagrisso (AZD9291, osimertinib) for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).
29 January 2016 | By Victoria White
The expanded label allows for the use of Daklinza (daclatasvir) in combination with sofosbuvir in HCV patients with decompensated cirrhosis, HIV-1 coinfection, and post-liver transplant recurrence of HCV...
28 January 2016 | By Victoria White
The European Commission has approved two new indications for Lilly’s Cyramza (ramucirumab): one in patients with NSCLC and the other in patients with mCRC...
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...
