Amgen has denied a request by the FDA to voluntarily withdraw its rare disease drug Tavneos from the market, the company said ...
On Amgen's call, the company's head of R&D, Jay Bradner, said the FDA's request for a voluntary withdrawal on 16th January ...
The "Data Integrity Auditor Masterclass Training Course (Apr 22nd - Apr 23rd, 2026)" training has been added to ResearchAndMarkets.com's offering. Data integrity has received more attention than ever ...
Chris is the CTO and Co-Founder of Scientist.com, a Research Platform helping drug discovery researchers develop new therapies. The FDA’s adoption of electronic submissions raised concerns about data ...
SUNNYVALE, Calif.--(BUSINESS WIRE)--#DvSum--DvSum, a leader in data intelligence management, is pleased to announce its partnership with Booz Allen Hamilton and the U.S. Food and Drug Administration ...
"EMA will now review all available data to assess whether this emerging information has an impact on the balance of benefits and risks of Tavneos," said the EU regulator. "The agency will then issue a ...
The EMA has started a review of Amgen Inc.’s Tavneos (avacopan) after questions were raised about the integrity of the data in the Advocate study that the agency assessed when granting approval of the ...
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