RGX-121 was rejected in early February, with Regenxbio listing the primary reasons given by the FDA as concerns about the ability to properly define a patient population, the use of a natural history ...
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 ...
Incyte is looking to expand the use of its PD-1 blocker Zynyz to treat non-small cell lung cancer. The FDA’s rejection did ...
In a complete response letter published by the FDA on Monday, the agency said a resubmission for REGENXBIO’s Hunter syndrome gene therapy should provide evidence of normalized or improved biomarker ...
A 1957 job rejection letter is causing a stir online because it awarded a rejected applicant with monetary compensation. 2026 ...
A high schooler wrote a rejection letter to her rejection letter from Duke. — -- Spring is here along with the angst of the college admissions process for high school seniors everywhere. One ...
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