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

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 released more than 200 of its so-called complete response letters from its archive on ...

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

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

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

By publishing more than 200 complete response letters, the FDA is offering new visibility into the issues that most often ...

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 ...

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 ...

Investing.com -- Ultragenyx Pharmaceutical (TADAWUL: 2070) Inc. (NASDAQ: RARE) stock fell over 5% after the company announced that the U.S. Food and Drug Administration (FDA) has issued a Complete ...