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4 May 2017 | By Niamh Marriott, Junior Editor
The drug is approved for use in combination with LeukoStrat CDx FLT3 Mutation Assay, which is used to detect the FLT3 mutation in patients with AML...
3 May 2017 | By Niamh Marriott, Junior Editor
The US Food and Drug Administration (FDA) has granted accelerated approval to AstraZeneca’s Imfinzi (durvalumab) to treat metastatic urothelial carcinoma...
3 May 2017 | By Niamh Marriott, Junior Editor
The EC has granted approval to Janssen Daralex (daratumumab) for use in combination, for the treatment of adult patients with multiple myeloma (MM)...
2 May 2017 | By Niamh Marriott, Junior Editor
The FDA has accepted the resubmission of Sanofi and Regeneron Pharmaceuticals’ Biologics License Application for Kevzara (sarilumab)...
2 May 2017 | By Niamh Marriott, Junior Editor
The FDA has expanded the approved use of Bayer's Stivarga (regorafinib) to include treatment of patients with hepatocellular carcinoma...
2 May 2017 | By Niamh Marriott, Junior Editor
NICE has recommended Stelara (ustekinumab) in its final appraisal determination as a treatment option for adult patients with Crohn’s disease...
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...
28 April 2017 | By Niamh Marriott, Junior Editor
Novartis announced data from the MS-MRIUS study, which confirmed the effectiveness of Gilenya (fingolimod) in the real-world setting...
28 April 2017 | By Niamh Marriott, Junior Editor
Results of the SARAH trial demonstrate that SIRT resulted in median overall survival (OS) of 8.0 months compared to 9.9 months with sorafenib (p=0.179)...
27 April 2017 | By SMi Group
Legal advisor and policy analyst to provide opening keynote on the Impact of the General Data Protection Regulation (GDPR) on collaborative science in Europe.
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).
27 April 2017 | By Niamh Marriott, Junior Editor
Novartis has expanded their commercialisation agreement with Amgen for AMG 334 (erenumab), which is being investigated for the prevention of migraine...
27 April 2017 | By Niamh Marriott, Junior Editor
Polyphor presented promising data for their novel class of antibiotics, the Outer Membrane Protein Targeting Antibiotics (OMPTA)...
26 April 2017 | By Niamh Marriott, Junior Editor
The FDA posted warning letters to 14 US-based companies illegally selling over 65 products that fraudulently claim to prevent, treat or cure cancer...
26 April 2017 | By Niamh Marriott, Junior Editor
Girish Malhotra argues time reduction for ANDA approvals, arguing that if the current approval time can be reduced, drug costs will decrease...
