Harmony Biosciences Holdings, Inc.
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Latest From Harmony Biosciences Holdings, Inc.
When Breakthrough Falls Short: US FDA Complete Response Letters Rising Among BTD Applications For Approval
More than half of the complete response letters issued for applications holding breakthrough status have been issued since 2020, reflecting difficult – and often rancorous – efficacy debates.
Private Company Edition: venBio’s new fund plus Ysios Capital’s recent €216m ($260m) fund adds up to $810m in fresh venture capital for life science companies. Also, Nikang and Esco attracted $200m each in VC investment, Pulmocide closed a $92m series C round and Stablix launched with $63m.
The European Medicines Agency today revealed the names of the latest new products it believes should be approved for use across the EU.
Several companies may appear this week before the European Medicines Agency’s human medicines committee, the CHMP, to answer questions about their initial marketing authorization applications or indication extension requests.
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