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 ...
The U.S. Food and Drug Administration (FDA) issued new draft guidance on October 29, 2025, proposing what it said were “major updates to simplify biosimilarity studies and reduce unnecessary clinical ...
Regenxbio (RGNX) shares fell after the U.S. Food and Drug Administration issued a complete response letter for RGX-121 (clemidsogene lanparvovec), its gene therapy candidate for the treatment of ...
FDA open to pooling data from ongoing Phase I/II studies of LX2006 with data from pivotal trial, and to earlier co-primary endpoint assessment, to support a Biologics License Application FDA approved ...
The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies for new drug approvals ...
The regulatory landscape for biosimilars is undergoing significant change on both sides of the Atlantic. Recent developments signal a potential shift away from the requirement for a clinical efficacy ...
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