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.

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

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 ...

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

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

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

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

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

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