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RSS FeedPosted by Michael Wonder on 23 Nov 2016
NICE recommends extra ‘triple therapy’ drug for treating type 2 diabetes
23 November 2016 - NICE has published final guidance recommending dapagliflozin for treating type 2 diabetes in ‘triple therapy’. ...
Posted by Michael Wonder on 23 Nov 2016
NICE reviews multiple myeloma drug and approves for routine use
23 November 2016 - Hundreds of patients set to benefit after NICE draft guidance recommends pomalidomide, a drug that treats some ...
Posted by Michael Wonder on 23 Nov 2016
Halaven cleared by TGA for sarcoma
23 November 2016 - Eisai bags a second use for its halichondrin B analogue. ...
Posted by Michael Wonder on 23 Nov 2016
TGA approves another Opdivo for another cancer type
23 November 2016 - The TGA has sanctioned the use of nivolumab for use by patients with renal cell carcinoma. ...
Posted by Michael Wonder on 22 Nov 2016
European Commission approves Bristol-Myers Squibb’s Opdivo (nivolumab) for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant and treatment with brentuximab vedotin
22 November 2016 - First and only PD-1 inhibitor approved for a haematologic malignancy in the European Union. ...
Posted by Michael Wonder on 22 Nov 2016
Sanofi receives FDA approval of Soliqua 100/33, for the treatment of adults with type 2 diabetes
21 November 2016 - Sanofi announced today that the U.S. FDA approved once-daily Soliqua 100/33 (insulin glargine & lixisenatide injection) ...
Posted by Michael Wonder on 22 Nov 2016
Mallinckrodt will initiate company-sponsored clinical trial of H.P. Acthar Gel in treatment of amyotropic lateral sclerosis
21 November 2016 - Investigational new drug application for use of H.P Acthar Gel in amyotropic lateral sclerosis awarded fast ...
Posted by Michael Wonder on 22 Nov 2016
U.S. FDA grants fast track designation for the development of Oragenics’ AG013 for oral mucositis
21 November 2016 - Oragenics today announced that the U.S. FDA granted fast track designation to AG013, the Company’s lead ...
Posted by Michael Wonder on 22 Nov 2016
Novo Nordisk receives US FDA approval for Xultophy 100/3.6
21 November 2016 - Novo Nordisk today announced that the US FDA has approved the new drug application for Xultophy 100/3.6. ...
Posted by Michael Wonder on 22 Nov 2016
Allergan announces receipt of additional Health Canada approval for Fibristal
21 November 2016 - Allergan announced that it has received an additional approval from Health Canada for Fibristal (ulipristal acetate, 5 ...
Posted by Michael Wonder on 22 Nov 2016
Genmab announces U.S. FDA approval of Darzalex (daratumumab) for relapsed multiple myeloma
21 November 2016 - Darzalex (daratumumab) approved by U.S. FDA in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for ...
Posted by Michael Wonder on 21 Nov 2016
Teva secures European approval of Trisenox for first-line treatment of low to intermediate risk acute promyelocytic leukaemia
21 November 2016 - Decision solely based on published academic data endorsing the benefit of Trisenox as first chemotherapy-free treatment for ...
Posted by Michael Wonder on 21 Nov 2016
GSK receives FDA approval for expanded indication for FluLaval Quadrivalent (influenza vaccine) for infants 6 months and older
18 November 2016 - GSK announced today it has received approval from the US FDA Center for Biologics Evaluation and ...
Posted by Michael Wonder on 20 Nov 2016
TGA approves Grifols' Prolastin C
17 November 2016 - The TGA has approved Grifols' new alfa-1-proteinase inhibitor. ...
Posted by Michael Wonder on 19 Nov 2016
Spectrum Pharmaceuticals says FDA rejects its bladder cancer drug
18 November 2016 - Spectrum Pharmaceuticals said on Friday the U.S. FDA had rejected its bladder cancer treatment, apaziquone. ...