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

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

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

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 Inc. (NASDAQ: RARE) stock fell over 5% after the company announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter ...

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

Some Colorado Springs residents claim the government system that provides federally subsidized housing vouchers to help ...