CNBC
US · 6 hrs ago
✦ 72◉ Centre
Replimune to resubmit twice-rejected drug for approval after FDA shakeup
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Quality 72/100
Partisan intensity 25/100
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◉ Centre ✓ Fair headline
Replimune plans to resubmit a drug application that was rejected twice by the FDA, following recent leadership changes at the agency. The company had previously criticized the FDA for providing inconsistent guidance on trial design and approval criteria.
Replimune to resubmit twice-rejected drug for approval after FDA shakeup
Replimune was among the drugmakers that had criticized the FDA for what they called inconsistent guidance around trials and approvals.
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