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The FDA is taking steps toward getting more patient input during the drug development process, a move that puts the agency more in line with its EU counterparts, agency officials said June 18 at the DIA annual meeting in Washington, D.C. 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issued a proposed wish-list of approaches to the development of drugs for Duchenne Muscular Dystrophy, the FDA issued draft guidance giving drugmakers more leeway in how those drugs are created. Read More
The European Medicines Agency last month 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 House of Representatives on July 10 approved the 21st Century Cures Act by a vote of 344 to 77, moving focus to the Senate where efforts have begun to develop comparable legislation. Read More
The UK’s healthcare costs regulator is recommending Daiichi Sankyo’s oral anticoagulant Lixiana as a cost-effective drug that causes less disruption to patients’ lives while treating blood clots in deep veins that could lead to fatal blockages. Read More
The European Medicines Agency has initiated a review of human papillomavirus vaccines to determine if product information should be updated, following reports of rare but serious conditions that may be associated with their use. Read More