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The FDA has delayed Clovis Oncology’s bid to approve its new lung cancer treatment, asking for additional trial data that could see the March 30 PDUFA date extended. Read More
The board of directors of Brazil’s Anvisa has suspended the deadline for companies to submit data for a new drug tracking system and is repealing the system’s implementing legislation. Read More
A ruling by the Court of Justice of the European Union has clarified when drug patents expire, in a decision that could prove lucrative for drugmakers even though it adds only a few days of patent protection. Read More