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

The FDA published over 200 response letters sent as replies to drug and biological product applications in order to increase transparency.

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

Ultragenyx Pharmaceutical has received a complete response letter (CRL) from the FDA concerning its BLA for UX111 (ABO-102).

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

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

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 published more than 200 of its so-called complete response letters to ...

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

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