complete response letter

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US FDA publishes 200 complete response letters from archive

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 insight into the reasons new drug and biologics applications got rejected.

· 1d · on MSN

US FDA publishes 200 complete response letters from archive in transparency drive

BioPharma Dive · 1d

FDA, in policy shift, publishes some drug rejection letters

The Manila Times14h

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 ...

BioSpace21h

Capricor Plunges on FDA Rejection of DMD Cell Therapy

In its complete response letter, the FDA cited insufficient evidence establish deramiocel's effectiveness for cardiomyopathy ...

17h

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 ...

14h

Ultragenyx Says Metabolic Disorder Treatment Approval Likely Delayed to 2026

Ultragenyx Pharmaceutical said federal regulators have issued a complete response letter to its application for a metabolic disorder treatment that may delay the potential approval to 2026.

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