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 US FDA has published more than 200 complete response letters, or decision letters, sent as replies to drug and biological product applications submitted to the agency from 2020 to 2024.

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 released more than 200 of its so-called complete response letters from its archive on ...

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

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

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

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

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

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