‘Dangling’ Accelerated Approval Reviews Expand At US FDA
The oncologic drugs advisory committee’s upcoming reviews are moving beyond the PD-1/PDL-1 inhibitor class – and to a very different type of sponsor.
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Keeping Track: US FDA Clears On Target’s Cytalux, VBI’s PreHevbrio; Keytruda Grows In Adjuvant Melanoma
The latest FDA approval news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.