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Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) is one of the best oversold NASDAQ stocks to buy now. On July 14, William Blair ...
The FDA cited manufacturing issues but did not flag problems with Ultragenyx’s data package for UX111, with the biotech ...
Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees ...
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Zacks Investment Research on MSNUltragenyx Pharmaceuticals Gets CRL for UX111 Gene Therapy for MPS IIIAUltragenyx Pharmaceuticals RARE announced that the FDA has issued a Complete Response Letter (CRL) for its biologics license ...
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GlobalData on MSNUltragenyx receives complete response letter for UX111 BLAThe FDA's request stems from observations made during recent inspections of Ultragenyx's manufacturing facilities.
While the CRL derails a near-term clearance, one analyst described the rejection as more of “a speed bump to approval, rather ...
Novato, California Monday, July 14, 2025, 16:00 Hrs [IST] ...
Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) is one of the stocks drowned heavily. Are you holding any? Ultragenyx fell by 26 ...
Olivia had been showing symptoms since she was just 7 months old — including a belly that remained swollen, hard to the touch and rounder than it should have been. Her pediatrician brushed it off as a ...
The firm said the agency cited chemistry, manufacturing, and controls issues in its complete response letter, but had no concerns about product quality.
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