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

By Stephanie Brown HealthDay ReporterTHURSDAY, July 10, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has ...

Capricor Therapeutics's dip caused by the CRL is a buying opportunity considering the readout of HOPE-3 within 2-3 months.

While the complete response letter derails a near-term clearance, one analyst described the rejection as more of “a speed ...

On July 10, 2025, the Food and Drug Administration (FDA) announced that it had published more than 200 complete response letters (CRLs), in ...

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

The US Food and Drug Administration (FDA) has announced the publication of more than 200 complete response letters (CRLs), ...

The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new ...

The FDA's request stems from observations made during recent inspections of Ultragenyx's manufacturing facilities.

A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...

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

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