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Breakthrough Designation Binge In February By US FDA Didn’t Extend To Approvals

Six new breakthrough therapy designations have been announced, all for novel agents, but approvals were fewer and limited to new indications and formulations.

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As Korean firms report quarterly earnings, Hanmi is stepping up the development of obesity drugs, Daewoong unveils plans to boost sales of in-house new drugs, GC Biopharma’s immunoglobulin undergoes the US approval process and Ildong has set up a new R&D-focused subsidiary.

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