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

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

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

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

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

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

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