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Keeping Track: Three Oncologics, A New Migraine Preventive, And First LPAD Antibiotic Clear US FDA

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The latest drug development news and highlights from our FDA Performance Tracker.  

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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trial enrollment challenges resulting from an evolving treatment landscape; 13 cancer indications now have been withdrawn since the FDA began cracking down on accelerated approvals that have not confirmed clinical benefit.

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Oncologic Drugs Advisory Committee will consider whether a statistically significant benefit on progression-free survival, but no survival advantage, is enough to secure a first-line lung cancer indication for ramucirumab.

Keeping Track: Industry Beefs Up 2020 Review Pipeline With Submissions Galore

The latest drug development news and highlights from our US FDA Performance Tracker.

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