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The FDA this week approved the first human recombinant C1-esterase inhibitor product for adolescents and adults with acute attacks of a rare condition called hereditary angioedema (HAE). Read More
Generics maker Ranbaxy has the green light to launch an exclusive version of Novartis’ blockbuster hypertension drug Diovan, a move that comes nearly two years after the drug lost patent protection. Read More
Salix Pharmaceuticals has convinced the FDA to reverse its 2012 stance blocking the company’s sNDA for an expanded use of its opioid-induced constipation drug Relistor. Read More
The UK’s drug watchdog agency has recommended coverage of Biogen Idec’s oral multiple sclerosis drug Tecfidera, reversing its negative decision issued in February. Read More
Manufacturer Hospira’s 2005 withdrawal of its leucovorin injection was not done for effectiveness or safety reasons, the FDA said, paving the way for new ANDAs on the generic anemia drug. Read More
A European public-private partnership is launching a new $4.5 billion decade-long effort to improve the success rate of clinical trials on certain drugs by 30 percent and boost exclusivity to make manufacturing treatments more enticing. Read More
The European Medicines Agency acted properly in rejecting a UK-based pharmaceutical company’s over-the-counter migraine medicine, the European ombudsman says. Read More