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FDA says "manipulated" data backed approval, moves to withdraw the drug
The FDA has moved to pull Tavneos (avacopan) from the U.S. market, alleging that manipulated clinical trial data propped up ...
Stoboclo and Osenvelt were approved as interchangeable biosimilars for bone loss conditions, potentially reducing costs and increasing access. Darzalex Faspro was approved for high-risk smoldering ...
The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.
The US Food and Drug Administration (FDA) on Wednesday released a draft guidance for public consultation providing recommendations for drugmakers on using the agency’s inactive ingredient database ...
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you ...
The Food and Drug Administration is asking Eli Lilly to gather more safety data on its new weight loss pill, Foundayo, including whether it could be linked to liver and heart problems, according to th ...
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