News

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 Dive2h
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 Supra4h
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 ...
PMLive6h
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), ...
Renal & Urology News4h
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 ...
Ultragenyx Pharmaceutical, Apple And Other Big Stocks Moving Lower In Monday's Pre-Market Session
Ultragenyx received a Complete Response Letter from the FDA for UX111 AAV gene therapy to treat Sanfilippo Syndrome Type A ...
Pharmabiz9h
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 ...
Pharmabiz12h
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 ...
STAT5hOpinion
The FDA commissioner is a gifted talker — but the job is about more than that
FDA Commissioner Marty Makary's vision for the agency risks the best of an agency that mostly has functioned well for the ...
Precision Medicine Online3h
FDA Declines to Approve Ultragenyx's Gene Therapy for Sanfilippo Syndrome Type A
The firm said the agency cited chemistry, manufacturing, and controls issues in its complete response letter, but had no concerns about product quality.
MyChesCo on MSN17h
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) ...