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Refuting testimony provided by CDER Director Janet Woodcock during a Senate HELP Committee hearing, Sen. Tom Cotton (R-Ark.) sent a letter to new FDA Commissioner Robert Califf seeking information on the agency’s ANDA backlog. Read More
The FDA sent PTC Therapeutics a refusal to file letter for Translarna, its candidate for the treatment of nonsense mutation Duchenne muscular dystrophy. 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
Six new drugs scored wins at the European Medicines Agency, scooping up recommendations for marketing authorization from the Committee for Medicinal Products for Human Use. Read More