List view / Grid view
28 April 2017 | By Niamh Marriott, Junior Editor
The European Medicine Agency's CHMP has adopted a positive opinion for the marketing authorisation of Sanofi and Regeneron Pharmaceuticals’ Kevzara...
27 April 2017 | By Niamh Marriott, Junior Editor
The European Commission (EC) has granted full marketing authorisation for AstraZeneca’s Tagrisso (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).
26 April 2017 | By Niamh Marriott, Junior Editor
CHMP has adopted a positive opinion for the company's MAA for Brineura to treat children with Neuronal Ceroid Lipofuscinosis Type 2 disease...
5 April 2017 | By Niamh Marriott, Junior Editor
The European Commission has approved Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) to treat fnon-small cell lung cancer...
27 February 2017 | By Niamh Marriott, Digital Editor
The EMA approved Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) to treat patients with non-small cell lung cancer...
23 February 2017 | By Niamh Marriott, Digital Editor
The European Commission has approved Truxima (biosimilar rituximab) for all indications of reference rituximab in the European Union.
19 January 2017 | By Niamh Marriott, Digital Editor
Suliqua is an innovative new combination therapy that has the potential to address significant unmet needs for people living with type 2 diabetes in Europe
28 November 2016 | By Niamh Louise Marriott, Digital Editor
It is the first time that a form of acute leukaemia can be effectively treated with a regimen that is entirely chemotherapy-free...
19 October 2016 | By Niamh Louise Marriott, Digital Content Producer
Non-inferiority was demonstrated in a Phase 3 trial for the co-primary endpoints of ongoing pregnancy rate and ongoing implantation rate for Rekovelle...
18 October 2016 | By Niamh Louise Marriott, Digital Content Producer
Cx601 is a suspension of allogeneic adipose-derived stem cells for the treatment of complex perianal fistulas in patients with Crohn's disease that have...
18 October 2016 | By Niamh Louise Marriott, Digital Content Producer
The CHMP recommends approval of venetoclax monotherapy in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have...
16 September 2016 | By Niamh Louise Marriott,
The European Commission has approved Ibsen’s cabometyx (cabozantinib) 20, 40, 60 mg tablets for the treatment of advanced renal cell carcinoma (RCC) in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy. Cabometyx (cabozantinib) demonstrated significant clinical benefits across all three efficacy endpoints (OS, PFS, ORR) in a phase 3…
13 September 2016 | By Niamh Louise Marriott, Digital Content Producer
Senscis is specifically evaluating nintedanib to understand the disease process and potential benefit of the compound to treat SSc-ILD...
2 September 2016 | By Niamh Louise Marriott, Digital Content Producer
The approval is based on data from the phase 3b clinical trial, which examined the efficacy and safety of liraglutide versus placebo as an add-on to existing diabetes medication, to improve glycaemic control...
9 August 2016 | By MSD
Following successful phase 3 clinical trials, in which MSD’s new Hepatitis C drug, Zepatier, performed well, achieving high virologic cure rates across the study, the European Commission has licensed the drug for sale in the European market, specifically for the treatment of chronic hepatitis C virus (HCV) in adults with…
