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

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 complete response letter derails a near-term clearance, one analyst described the rejection as more of “a speed ...

The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new ...

(HealthDay News) — The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as replies to drug and biological product applications ...

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

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 ...

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

The firm said the agency cited chemistry, manufacturing, and controls issues in its complete response letter, but had no concerns about product quality.

The fire that burned for days on the North Rim of Grand Canyon before it became uncontrollable was "expertly handled," the ...

After the announcement of a 30% surcharge on all European products, the 27 member states are opting for a three-pronged ...

Following Wyoming’s lead, Montana’s congressional delegation is pushing to reverse Biden-era BLM rules that would end coal ...