The U.S. Food and Drug Administration released more than 200 of its so-called complete response letters from its archive on ...

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

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

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

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

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

The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...

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

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

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 ...

Ultragenyx Pharmaceutical said federal regulators have issued a complete response letter to its application for a metabolic disorder treatment that may delay the potential approval to 2026.

One of the major complaints levied against FDA by the current administration is that the approval process is too complicated, takes too long, and needs to be modernized. The new leadership pledged to ...