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The European Medicines Agency Wednesday released final guidance on the primary and secondary endpoints sponsors should use to evaluate drugs to treat acute heart failure — along with recommendations on designing and conducting such studies in children. Read More
The FDA has granted breakthrough therapy status for Genentech's scleroderma treatment Actemra, guaranteeing the drug a six-month review rather than the usual 10 months. Read More
The Australian government has developed a framework for measuring the performance of its regulatory agencies, in an effort to increase transparency and cut down on practices that impede the operations of regulated industries. Read More
The Endocrinologic and Metabolic Drugs Advisory Committee voted 13 to 3 Tuesday to recommend approval of Sanofi and Regeneron’s cholesterol-lowering drug Praluent, but said more data is needed to support the drug’s effect on cardiovascular outcomes. Read More
A year after a consortium of stakeholders issued a proposed wish-list of approaches to the development of drugs for Duchenne Muscular Dystrophy, the FDA yesterday issued draft guidance giving drugmakers more leeway in how those drugs are created. Read More
Mylan is expanding its nationwide recall of injectable gemcitabine and methotrexate to the hospital and user level, recalling eight more lots of the drugs after foreign matter was seen during quality control tests. Read More
Shire’s blockbuster attention deficit hyperactivity disorder drug Intuniv is facing competition as four generic versions of the therapy hit the U.S. market. Read More