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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
The FDA has asked for more information on the pen injector device used in Sanofi and Zealand Pharma’s IGlarLixi combination product for diabetes, extending its review by three months. Read More
The EMA is trying to simplify data integrity compliance by compiling all of its expectations into a single document that covers the entire data integrity lifecycle. Read More