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 ...

The US Food and Drug Administration (FDA) has announced the publication of more than 200 complete response letters (CRLs), ...

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

(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 ...

US FDA accepts for review Milestone Pharma’s response to CRL for Cardamyst nasal spray: Montreal Monday, July 14, 2025, 11:00 Hrs [IST] Milestone Pharmaceuticals Inc., a biophar ...

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 ...

US FDA embraces radical transparency by publishing complete response letters: Maryland Monday, July 14, 2025, 14:00 Hrs [IST] The US Food and Drug Administration (FDA) published m ...

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

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