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RSS FeedPosted by Michael Wonder on 13 Dec 2016
FDA approves first autologous cellularized scaffold for the repair of cartilage defects of the knee
14 December 2016 - The U.S. FDA today approved Maci (autologous cultured chondrocytes on porcine collagen membrane) for the repair of ...
Posted by Michael Wonder on 13 Dec 2016
European Commission grants marketing authorization for Arzerra (ofatumumab) in combination with fludarabine and cyclophosphamide in relapsed CLL
12 December 2016 - Approval based on data from Phase III COMPLEMENT 2 trial. ...
Posted by Michael Wonder on 13 Dec 2016
Pediapharm receives Health Canada approval for Otixal
12 December 2016 - Pediapharm is very pleased to announce Health Canada's approval of Otixal (ciprofloxacin 0.3 % and fluocinolone ...
Posted by Michael Wonder on 13 Dec 2016
Emergent BioSolutions receives Health Canada approval for botulism anti-toxin
12 December 2016 - Emergent BioSolutions today announced that Health Canada has approved the company’s new drug submission for its botulism ...
Posted by Michael Wonder on 12 Dec 2016
U.S. FDA approves Synjardy XR (empagliflozin/metformin hydrochloride extended-release) tablets for adults with type 2 diabetes
12 December 2016 - New once-a-day formulation indicated to improve blood sugar when used along with diet and exercise ...
Posted by Michael Wonder on 09 Dec 2016
Cipla receives final FDA approval for generic Baraclude tablets
8 December 2016 - Cipla has received final approval for its abbreviated new drug application for entecavir 0.5 mg and ...
Posted by Michael Wonder on 09 Dec 2016
Biogen and AbbVie receive Health Canada approval of once monthly Zinbryta (daclizumab beta) for multiple sclerosis
9 December 2016 - Approval supported by largest and longest head-to-head global Phase 3 study conducted in multiple sclerosis. ...
Posted by Michael Wonder on 08 Dec 2016
European Commission grants conditional marketing approval for AbbVie's Venclyxto (venetoclax) monotherapy for appropriate patients with difficult-to-treat chronic lymphocytic leukaemia
8 December 2016 - Venclyxto is the first approved BCL-2 inhibitor in Europe. ...
Posted by Michael Wonder on 07 Dec 2016
FDA approves Genentech’s Avastin (bevacizumab) plus chemotherapy for a specific type of advanced ovarian cancer
6 December 2016 - In the United States, Avastin is now approved for nine distinct uses across six different types ...
Posted by Michael Wonder on 07 Dec 2016
Novartis' Lucentis receives EU approval in new indication
7 December 2016 - The European Commission approved Lucentis to treat patients for visual impairment due to choroidal neovascularization associated with ...
Posted by Michael Wonder on 07 Dec 2016
Theravance Biopharma receives FDA fast track designation for velusetrag (TD-5108) for idiopathic and diabetic gastroparesis
6 December 2016 - Results from ongoing phase 2b study in gastroparesis expected in mid 2017. ...
Posted by Michael Wonder on 06 Dec 2016
Antizol approved by TGA
5 December 2016 - The TGA has approved a new medicine from AFT Pharmaceuticals. ...
Posted by Michael Wonder on 05 Dec 2016
Nocdurna approved by TGA
5 December 2016 - The TGA has approved a new indication for Ferring's desmopressin acetate. ...
Posted by Michael Wonder on 05 Dec 2016
TGA approves AbbVie's Technivie
5 December 2016 - The TGA has approved another AbbVie combination product for use by patients with chronic hepatitis C ...
Posted by Michael Wonder on 02 Dec 2016
FDA approves Jardiance to reduce cardiovascular death in adults with type 2 diabetes
2 December 2016 - The U.S. FDA today approved a new indication for Jardiance (empagliflozin) to reduce the risk of cardiovascular ...