While the CRL derails a near-term clearance, one analyst described the rejection as more of “a speed bump to approval, rather ...

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

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

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

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

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

The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.

The FDA has released an “initial batch“ of more than 200 complete response letters (CRLs) in efforts to boost transparency. | ...

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

The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...

When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided an in-depth view | ...