Ultragenyx Pharmaceutical has received a complete response letter (CRL) from the FDA concerning its BLA for UX111 (ABO-102).

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

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

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

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

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

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

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

When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided an in-depth view | ...

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

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 ...

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