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

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

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

FDA Commissioner Marty Makary's vision for the agency risks the best of an agency that mostly has functioned well for the ...

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

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

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

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. | ...

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 ...

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