FDA’s CRLs reveal critical errors in AstraZeneca’s Saphnelo data, efficacy doubts for GSK’s Exdensur
In a scathing rebuke (PDF) to AstraZeneca, the FDA cited “critical data quality issues that affect key analyses, including the primary endpoint” within a dataset for Saphnelo (anifrolumab) for the ...
Insight Molecular Diagnostics Completes Key Milestones Advancing GraftAssureDx Toward FDA Submission
U.K. and E.U. regulatory submissions NASHVILLE, Tenn., (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc. (Nasdaq: IMDX) (“iMDx”) today announced that in February the company completed several ...
In a complete response letter published by the FDA on Monday, the agency said a resubmission for REGENXBIO’s Hunter syndrome ...
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