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FDA Publishes Full Texts of Response Letters to Drug Applications
By Stephanie Brown HealthDay ReporterTHURSDAY, July 10, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has ...
US FDA publishes 200 complete response letters from archive in transparency drive
The U.S. Food and Drug Administration released more than 200 of its so-called complete response letters from its archive on ...
Capricor Therapeutics: Buying Opportunity Following FDA's Complete Response Letter
Capricor Therapeutics's dip caused by the CRL is a buying opportunity considering the readout of HOPE-3 within 2-3 months.
BioPharma Dive3h
FDA rejects Ultragenyx gene therapy over manufacturing concerns
While the complete response letter derails a near-term clearance, one analyst described the rejection as more of “a speed ...
JD Supra5h
FDA Publishes More Than 200 Complete Response Letters (CRLs) With More to Come
On July 10, 2025, the Food and Drug Administration (FDA) announced that it had published more than 200 complete response letters (CRLs), in ...
BioSpace3d
FDA Publishes Cache of Complete Response Letters in Bid for ‘Radical Transparency’
The trove of more than 200 letters is part of a pledge of transparency from the agency, with the intention to increase public ...
PMLive7h
FDA publishes over 200 complete response letters in effort to increase transparency
The US Food and Drug Administration (FDA) has announced the publication of more than 200 complete response letters (CRLs), ...
Fierce Pharma4h
Ultragenyx takes another hit as FDA snubs AAV gene therapy over manufacturing issues
The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new ...
BioSpace3d
FDA Rejections: We Read 200 CRLs So You Don’t Have To
A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...
Capricor: Maintaining Hold Rating In Light Of Deramiocel Complete Response Letter
Capricor Therapeutics is expected to release data from the phase 3 HOPE-3 trial in Q3'25, thus presenting a potential path ...
pharmaphorum3d
Just how radical is the FDA's complete response letter move?
The FDA has called a plan to publish certain complete response letters (CRLs) for medicines it has rejected after an initial ...
The Manila Times2d
Ultragenyx Receives Complete Response Letter from FDA for UX111 AAV Gene Therapy to Treat Sanfilippo Syndrome Type A (MPS IIIA)
Complete Response Letter (CRL) cited specific chemistry, manufacturing and controls (CMC) related observations that are ...