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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…
15 July 2016 | By Victoria White, Digital Content Producer
Celgene’s Revlimid (lenalidomide) has been approved by the EC for the treatment of adult patients with relapsed or refractory mantle cell lymphoma...
7 July 2016 | By Victoria White, Digital Content Producer
The EC has granted an extension of the Market Authorisation for Revestive for the treatment of patients aged one year and above with Short Bowel Syndrome...
6 July 2016 | By Victoria White, Digital Content Producer
The EC has extended the current conditional marketing authorisation of Adcetris as consodlidation treatment in post-transplant Hodgkin lymphoma...
5 July 2016 | By Victoria White, Digital Content Producer
The approval of Zinbryta is supported by results from two studies, including DECIDE, the largest and longest head-to-head Phase III study ever conducted in MS...
4 July 2016 | By Victoria White, Digital Content Producer
The EC has approved a variation to the marketing authorisation for Amgen’s Kyprolis (carfilzomib) to include use in combination with dexamethasone alone...
28 June 2016 | By Victoria White, Digital Content Producer
The EC has granted marketing authorisation for Zavicefta for the treatment of patients with serious Gram-negative bacterial infections...
23 June 2016 | By Victoria White, Digital Content Producer
The EC has granted marketing authorisation for Gilead’s once-daily single tablet regimen Odefsey for the treatment of HIV-1 infection in certain patients...
The European Commission has approved Roche’s Gazyvaro (obinutuzumab) in combination with bendamustine chemotherapy followed by Gazyvaro maintenance in people with follicular lymphoma.
