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The European Medicines Agency has issued draft guidance describing the types of evidence developers of gene therapies need to support marketing authorization — saying very small firms, which comprise the majority of this segment, may not be familiar with the regulatory process. Read More
The House Energy & Commerce Committee released a new version of the 21st Century Cures Act that scales back the rare pediatric disease priority review voucher program. Read More
The FDA has revised Bristol-Myers Squibb’s breakthrough therapy designation for its daclatasvir/sofosbuvir combination hepatitis C therapy to cover patients with advanced cirrhosis or whose infection recurs after a liver transplant. Read More
The U.S. Supreme Court has rejected the third and final request for review of a Pennsylvania state court ruling that would allow individuals to sue generics makers for failing to update warnings on drug labels. Read More