JD Supra

FDA Publishes Complete Response Letters for Unapproved Drug Applications

On September 4, 2025, the US Food and Drug Administration (FDA or the Agency) announced that it released a second batch of complete response letters (CRLs) — which explain the Agency’s determination ...
Monthly Prescribing Reference

FDA Publishes Full Texts of Response Letters to Drug Applications

The issues addressed in these letters are usually related to "safety and efficacy concerns, manufacturing deficiencies, and bioequivalence issues." HealthDay News — The US Food and Drug Administration ...
Healio

FDA again rejects tabelecleucel for EBV-driven post-transplant lymphoproliferative disease

The FDA has issued a second complete response letter to Atara Biotherapeutics for its biologicals license application of ...
KTLA

Saol Therapeutics Receives Complete Response Letter from FDA for SL1009 (DCA) for the Treatment of Pyruvate Dehydrogenase Complex Deficiency (PDCD)

ROSWELL, Ga. and DUBLIN and HAMILTON, Bermuda, Sept. 8, 2025 /PRNewswire/ -- Saol Therapeutics, a privately held, clinical-stage pharmaceutical company, today announced that the U.S. Food and Drug ...
Seeking Alpha

Ultragenyx Receives Complete Response Letter from FDA for UX111 AAV Gene Therapy to Treat Sanfilippo Syndrome Type A (MPS IIIA)

NOVATO, Calif., July 11, 2025 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (RARE), today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) ...
JD Supra

FDA Commissioner Makary Promises “Real Time” Release of Complete Response Letters: Can FDA Really Do That?

On July 10, 2025, in the name of embracing “radical transparency,” the U.S. Food and Drug Administration (“FDA”) announced that it was publishing more than 200 complete response letters (“CRLs”) 1 ...
Seeking Alpha

FDA publishes more than 200 rejection letters in a bid to improve transparency

The U.S. Food and Drug Administration (FDA) on Thursday published more than 200 complete response letters ((CRLs)), through which drugmakers are informed about the agency’s rejections of their ...
FierceBiotech

‘Weak’ evidence and an ‘unpleasant’ odor: FDA sheds light on drug refusal process

When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided an in-depth view into the high-stakes discussions that decide whether a medicine will ever make ...
MedCity News

Embracing Transparency, FDA Will Make All Future Drug Rejection Letters Public

The next time the FDA turns down a drug application, the letter outlining the decision and the regulator’s reasoning will become public record. The agency said it will release future complete response ...
Renal & Urology News

FDA Publishes Full Texts of Response Letters to Drug Applications

The goal is to improve public understanding of the FDA decision-making process. (HealthDay News) — The U.S. Food and Drug Administration has published more than 200 complete response letters, or ...
Nasdaq

Ultragenyx Pharmaceutical Inc. Receives Complete Response Letter from FDA for UX111 Gene Therapy for Sanfilippo Syndrome Type A

Ultragenyx received a Complete Response Letter from the FDA regarding its UX111 therapy for Sanfilippo syndrome type A, citing manufacturing observations. Ultragenyx Pharmaceutical Inc. announced that ...