The U.S. Food and Drug Administration on Thursday publicly shared over 200 archived so-called complete response letters ...

The trove of more than 200 letters is part of a pledge of transparency from the agency, with the intention to increase public ...

The FDA has released an “initial batch“ of more than 200 complete response letters (CRLs) in efforts to boost transparency. | ...

The U.S. Food and Drug Administration on Thursday published more than 200 of its so-called complete response letters to ...

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

The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...

Capricor Therapeutics is expected to release data from the phase 3 HOPE-3 trial in Q3'25, thus presenting a potential path ...

Capricor Therapeutics (NASDAQ:CAPR) shares fell Friday after the company announced it received a complete response letter from the U.S. Food and Drug Administration for its Biologics License ...

The FDA has called a plan to publish certain complete response letters (CRLs) for medicines it has rejected after an initial ...

Complete Response Letter (CRL) cited specific chemistry, manufacturing and controls (CMC) related observations that are ...

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

HealthDay News — The US Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as replies to drug and biological product applications submitted ...