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

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 ...

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

FDA says the move boosts regulatory transparency, offering insights into common approval barriers in drug applications and reducing guesswork.

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 ...

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.

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 ...

The company said it was optimistic that the issues identified by the Food and Drug Administration could be resolved with new data.

Milestone Pharmaceuticals shares rose 18% in premarket trading after disclosing that the Food and Drug Administration accepted for review its response to issues raised in the complete response letter ...

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 ...