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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
To achieve the national cancer moonshot’s goal of accelerating cancer research, the FDA is planning to encourage more seamless, adaptive clinical trial designs for oncologic drugs. Read More
In the EU, biosimilars are poised to join the main market as prescribers widely embrace the lower-cost, copycat versions of the brand-name drugs. 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