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If Mylan wants to improve access to its emergency allergy treatment EpiPen, then the company should lower the price of the drug, instead of marketing a generic version, members of the House Committee on Oversight and Government Reform said Wednesday. Read More
Several senators expressed doubts that the FDA should take on the regulation of tens of thousands of laboratory-developed tests currently being used across the country, during a committee hearing on the future of regulation in an age of precision medicine. Read More
The FDA hopes to refine the review process and fee structure for biosimilar products in the next iteration of the Biosimilar User Fee Act to improve efficiency and resource availability. Read More
The FDA should promote greater patient involvement in development of drugs and other treatments for diseases, the National Health Council said in a set of priority considerations for the next presidential administration. Read More
The European Medicines Agency has recommended that three medicines manufactured by Pharmaceuticals International no longer be available in the EU due to possible cross-contamination. Read More
The FDA granted accelerated approval to Sarepta’s Exondys 51—the first drug indicated for the treatment of Duchenne muscular dystrophy—despite reservation from FDA staff and an advisory panel. Read More