Keeping Track: Pediatric Approvals, Seres Starts C Diff Submission, And BMS Pulls Reblozyl sBLA Before Possible CRL
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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BMS’s Phase III Reblozyl Trial Hits Mark In First-Line, Lower-Risk Myelodysplastic Syndrome
The drug’s success in the Phase III COMMANDS trial could double its addressable market, though some analysts said durability remains a question.
FDA’s Fecal Transplant Enforcement Discretion May Jeopardize Rebiotix’s Approval Prospects
A 2013 FDA decision to allow certain fecal microbiota transplants for C. difficile infection without an investigational new drug application hurt Rebiotix’s Phase III trial enrollment and may ultimately leave it without strong enough data for advisory committee endorsement or FDA approval.
SIFI’s Parasitic Eye Infection Drug & Biosimilar Aflibercept Among Raft Of EU Filings
Polyhexanide, from SIFI, could become the first approved treatment for acanthamoeba keratitis, while aflibercept could become the first biosimilar version of Eylea in the EU.