For instance, "the backlog of FOIAs ... is enormous," he said. Califf said the FDA has far greater opportunities for improved ...

The FDA accepted Aldeyra's resubmitted NDA for reproxalap after previous rejections due to efficacy concerns, despite no ...

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 ...

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 ...

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 ...

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

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 ...

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 ...

Investing.com -- Ultragenyx Pharmaceutical (TADAWUL: 2070) Inc. (NASDAQ: RARE) stock fell over 5% after the company announced that the U.S. Food and Drug Administration (FDA) has issued a Complete ...