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 FDA published a database containing more than 200 letters to pharmaceutical companies detailing why the agency initially refused to approve their products, The New York Times reported July 10. FDA ...

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

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

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

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

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