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Two GOP senators are sounding off on the FDA over an advisory committee recommendation against Sarepta’s Duchenne muscular dystrophy treatment eteplirsen. Read More
The UK’s National Institute for Health and Care Excellence says it will not recommend Roche’s Perjeta, raising concerns about the lack of evidence backing the drug’s long-term benefits. Read More
The EMA’s Committee for Medicinal Products for Human Use is recommending approval for six drugs within the EU and another for export-only from EU countries. Read More
In response to industry concerns about the FDA’s handling of biosimilar applications, the agency is looking to establish a dedicated biosimilar review unit as part of BsUFA reauthorizations. Read More