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Johnson & Johnson and Novartis each scored a victory in the UK, with the National Institute for Health and Care Excellence backing their respective treatments for prostate cancer and heart failure. Read More
Small drugmaker Fabre-Kramer Pharmaceuticals won a big victory Thursday after the FDA ignored its own internal advisory committee recommendations and negative determinations by the Office of New Drugs’ Office of Drug Evaluation I. Read More
Two lawmakers have unveiled legislation intended to boost the FDA’s ability to hire and retain scientific and technical experts to review drug applications. Read More
The European Medicines Agency has outlined the steps companies should follow once they secure orphan status for a medical product to maintain that status and secure marketing authorization. Read More
Six new drugs have scored wins at the European Medicines Agency, scooping up recommendations for marketing authorization from the Committee for Medicinal Products for Human Use. Read More
An NHS England spokesperson confirmed Feb. 18 that the agency will investigate whether more than 130 NHS staff involved in assessing drugs were also paid as consultants by drugmakers. Read More
After years of uncontrolled spending, the UK’s troubled Cancer Drugs Fund has presented the National Health Service with a restructuring plan to get back on track. Read More