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Keeping Track: US FDA Clears On Target’s Cytalux, VBI’s PreHevbrio; Keytruda Grows In Adjuvant Melanoma

Executive Summary

The latest FDA approval news and highlights from the Pink Sheet’s US FDA Performance Tracker.

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Bad Times For Breakthrough Drugs Targeting Chemo Complications; Submissions From BMS, Merck

The latest news about applications under FDA review, from the Pink Sheet’s US FDA Performance Tracker

US FDA Cancels Panel Review Of Two ‘Delinquent’ Cancer Drug Accelerated Approvals

Confirmatory trial for Secura Bio’s Farydak has been delayed for several years, while the study for Acrotech’s Marqibo was terminated early; a 2 December advisory committee meeting to consider the drugs’ fate was cancelled, which could mean the sponsors reached new study agreements with the FDA or plan to withdraw the drugs.

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