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.
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The European Medicines Agency will likely decide this week whether to recommend for pan-EU approval new treatments for insomnia, uveal melanoma, migraine and advanced prostate cancer.
Gilead pulls Zydelig’s third-line indications in follicular B-cell lymphoma and small lymphocytic lymphoma due to confirmatory trial enrollment challenges resulting from an evolving treatment landscape; 13 cancer indications now have been withdrawn since the FDA began cracking down on accelerated approvals that have not confirmed clinical benefit.
How has FDA suddenly been able to enforce accelerated approval commitments in oncology? The agency’s Richard Pazdur reflects on lessons from 2021 – and promises more re-reviews to come.