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 ...

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

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

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 ...

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

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

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

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 ...

Complete Response Letter (CRL) cited specific chemistry, manufacturing and controls (CMC) related observations that are ...

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