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The European Commission has approved Roche's Avastin plus chemotherapy for women with persistent, recurrent or metastatic cervical cancer, the company said Wednesday. Read More
The European Medicines Agency has approved a new use of Amgen’s Vectibix as first-line treatment in combination with Folfiri chemotherapy for metastatic colorectal cancer, the drugmaker said Monday.
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The FDA issued priority review vouchers to sponsors of two rare pediatric disease therapies, United Therapeutics’ cancer drug Unituxin and Asklepion Pharmaceuticals’ Cholbam for a severe metabolic disorder. Read More
The European Medicines Agency has greenlighted AbbVie’s Humira for the treatment of severe chronic plaque psoriasis in children and adolescents who have had an inadequate response to or are poor candidates for topical and photo therapies. Read More
Pharmaceutical companies can expect to wait about 165 days for Health Canada to make a final decision on appeals of an approval or rejection of a drug, according to Wednesday guidance that sets specific timelines for every step of the dispute resolution process. Read More
The European Medicines Agency has released its recommendations for the 2015/2016 seasonal influenza vaccine composition, setting the clock for when manufacturers have to submit their strain variation applications to June 15. Read More
Sanofi Pasteur’s new combined Quadracel DTaP plus polio vaccine is about to hit the U.S. market for children four to six years old, following FDA approval Wednesday. Read More