Health care professionals can have a powerful impact on labeling requirements for drugs by formally petitioning the FDA for ...
FDA turns up the heat: Federal regulators are requesting more safety information from drugmakers on products meant to protect ...
A top FDA official has proposed broad changes to the review and approval process for vaccines, citing a new internal review linking the deaths of 10 children to COVID-19 vaccines. In an internal memo ...
Key milestone achieved as Company advances clinical program to full approval trial of ateganosine sequenced with a checkpoint inhibitor in ...
Agios is collaborating closely with the FDA to finalize the labeling documents and Risk Evaluation and Mitigation Strategy (REMS) materials. The FDA has not requested, and the company has not ...
US FDA's vaccine director Dr. Vinay Prasad wrote a memo to their staff that claimed multiple child deaths were related to ...
The U.S. Department of Justice's recent subpoenas and the Hsiao Declaration signal a potential redefinition of enforcement boundaries under the ...
Democratic senators have introduced a new bill to create a federal regulatory framework for hemp-derived cannabinoids and ...
A warning over shredded cheese is the latest of hundreds in the U.S. food system. Understanding recalls can help shoppers ...
Gene one of nine companies awarded CDRP per yearProgram aims to support CMC development of products with expedited clinical development timeframes and provide patients with earlier access to these ...
Detailed price information for Arcutis Biotherapeutics Inc (ARQT-Q) from The Globe and Mail including charting and trades.
Longstanding regulatory and testing gaps have historically been filled by third-party groups with questionable methods.
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