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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issued a proposed wish-list of approaches to the development of drugs for Duchenne Muscular Dystrophy, the FDA issued draft guidance giving drugmakers more leeway in how those drugs are created.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
Otsuka and H. Lundbeck expect to launch once-daily Rexulti as a treatment for schizophrenia and add-on therapy for major depressive disorder in early August, following FDA approval Monday. Read More
AstraZeneca’s kinase inhibitor Iressa received FDA approval Monday as the first and only first-line treatment for patients with metastatic non-small cell lung cancer whose tumors have certain types of gene mutations, along with a companion diagnostic. Read More