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 ...
Cathy Burgess, Benjamin Wolf, Jong Ho "Philip" Won, Ph.D. The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, ...
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 ...
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 ...
"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 US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) just issued a joint statement outlining 10 “Guiding Principles” ...
In the latest bunch of recommendations from the European Medicines | Sanofi, Novo Nordisk, UCB and others received positive ...
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 ...
From lab bench to publication: integrity travels with you In research, digital images, including gel electrophoresis and ...
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