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Fierce Pharma53m
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 ...
JD Supra1h
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 ...
Renal & Urology News1h
FDA Publishes Full Texts of Response Letters to Drug Applications
(HealthDay News) — The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as replies to drug and biological product applications ...
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.
PMLive3h
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), ...
Pharmabiz6h
US FDA embraces radical transparency by publishing complete response letters
US FDA embraces radical transparency by publishing complete response letters: Maryland Monday, July 14, 2025, 14:00 Hrs [IST] The US Food and Drug Administration (FDA) published m ...
Pharmabiz9h
US FDA accepts for review Milestone Pharma’s response to CRL for Cardamyst nasal spray
US FDA accepts for review Milestone Pharma’s response to CRL for Cardamyst nasal spray: Montreal Monday, July 14, 2025, 11:00 Hrs [IST] Milestone Pharmaceuticals Inc., a biophar ...
MyChesCo on MSN14h
FDA Publishes Over 200 Complete Response Letters to Increase Drug Approval Transparency
In a landmark move to improve transparency and modernize regulatory processes, the U.S. Food and Drug Administration (FDA) ...