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Additional complete response (CR) observed in patient with multiple tumorsConfirmed overall response rate (ORR) of 50% in patients with combined positive score (CPS) ≥1, including 50% ORR in patients ...

Sebas, I speak to you now directly. God has you as his target, you’ll have no peace, no joy, no rest, no satisfaction until you yield to Him! Do not be like the rich young ruler who when asked by ...

Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees ...

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

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

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

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

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.