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RSS FeedPosted by Michael Wonder on 01 Apr 2016
New gene therapy for the treatment of children with ultra-rare immune disorder recommended for approval
1 April 2016 - The EMA has recommended granting a marketing authorisation in the European Union for a new gene therapy ...
Posted by Michael Wonder on 01 Apr 2016
First oral treatment for Fabry disease recommended for approval in the EU
1 April 2016 - The EMA has recommended granting a marketing authorisation in the European Union for Galafold (migalastat hydrochloride) for ...
Posted by Michael Wonder on 01 Apr 2016
New treatment for patients with multiple myeloma
1 April 2016 - The EMA has recommended granting a conditional marketing authorisation for Darzalex (daratumumab) for the treatment of adults ...
Posted by Michael Wonder on 30 Mar 2016
Newron receives complete response letter from US FDA for Xadago (safinamide mesylate)
29 March 2016 - Newron Pharmaceuticals and US WorldMeds announced today that a complete response letter from the FDA has been ...
Posted by Michael Wonder on 30 Mar 2016
OPKO Health receives complete response letter from FDA for Rayaldee new drug application
30 March 2016 - OPKO Health announces that the U.S. FDA has issued a complete response letter (CRL) to the company's ...
Posted by Michael Wonder on 30 Mar 2016
FDA approves first treatment for rare disease in patients who receive stem cell transplant from blood or bone marrow
30 March 2016 - The U.S. FDA today approved Defitelio (defibrotide sodium) to treat adults and children who develop hepatic veno-occlusive ...
Posted by Michael Wonder on 29 Mar 2016
Lundbeck and Takeda receive complete response letter by the FDA for Brintellix (vortioxetine hydrobromide) sNDA
29 March 2016 - Takeda and Lundbeck today announced that the U.S. FDA has issued a complete response letter (CRL) for ...
Posted by Michael Wonder on 27 Mar 2016
Welsh Government overrules NICE's rejection of Celgene's pancreatic cancer drug Abraxane
18 March 2016 - Patients with pancreatic cancer living in Wales will no doubt welcome news that Celgene’s Abraxane will continue ...
Posted by Michael Wonder on 23 Mar 2016
SMC allows wider use of Gedeon Richter's Esmya (ulipristal acetate)
23 March 2016 - The Scottish Medicines Consortium has approved funding for the use across NHS Scotland of a uterine fibroid ...
Posted by Michael Wonder on 23 Mar 2016
NICE consults on draft guidance for new cystic fibrosis treatment
23 March 2016 - NICE has issued draft guidance which does not recommend Orkambi (lumacaftor-ivacaftor marketed by Vertex Pharmaceuticals) for treating ...
Posted by Michael Wonder on 23 Mar 2016
FDA approves Cinqair to treat severe asthma
23 March 2016 - The U.S. Food and Drug Administration today approved Cinqair (reslizumab) for use with other asthma medicines for ...
Posted by Michael Wonder on 23 Mar 2016
Action receives approval for Uptravi (selexipag) for the treatment of pulmonary arterial hypertension in Australia and New Zealand
22 March 2016 - Actelion announced today that the Therapeutic Goods Administration (TGA) of Australia and the New Zealand Medicines and ...
Posted by Michael Wonder on 22 Mar 2016
FDA approves new psoriasis drug Taltz (ixekizumab)
22 March 2016 - The U.S. Food and Drug Administration today approved Taltz (ixekizumab) to treat adults with moderate-to-severe plaque psoriasis. ...
Posted by Michael Wonder on 22 Mar 2016
Horizon Pharma plc receives Health Canada approval for Ravicti (glycerol phenylbutyrate) oral liquid for the treatment of urea cycle disorders in patients two years of age and older
21 March 2016 - Horizon Pharma today announced that Health Canada has issued a Notice of Compliance (NoC) for Ravicti (glycerol ...
Posted by Michael Wonder on 21 Mar 2016
NICE recommends abiraterone acetate for prostate cancer
21 March 2016 - NICE has issued final guidance recommending abiraterone (marketed as Zytiga by Janssen) for some prostate cancer patients*. ...