FDA's Oncologic Drugs Advisory Committee votes 6-0 for withdrawal of bevacizumab's accelerated approval for first-line metastatic breast cancer, despite Genentech's argument that the indication should be maintained while it conducts another confirmatory trial.
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A new ordinance for addressing drug shortages in Austria requires drug companies distributing any of the hundreds of products listed in an accompanying annex to maintain adequate stock in the country to meet patient demand for four months.
The European Medicines Agency has for the first time explicitly stated it is considering the use of large language models as a tool to improve the readability of a scientific guideline.
England’s health technology assessment institute, NICE, must ensure that there is clarity for manufacturers on how its methods and processes might change following testing in its sandbox environment, the Association of the British Pharmaceutical Industry said.
