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

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

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

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

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

The U.S. Food and Drug Administration on Thursday published more than 200 of its so-called complete response letters to ...

Ultragenyx received a Complete Response Letter from the FDA for UX111 AAV gene therapy to treat Sanfilippo Syndrome Type A ...

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. | ...

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 ...

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