News
On July 2, linvoseltamab-gcpt (Lynozyfic; Regeneron) received an accelerated approval from the FDA in relapsed/refractory ...
Explore the FDA’s 2025 Human Foods Program Guidance Agenda and what it means for US food and beverage businesses. Key ...
Among 24 such systems (called devices in FDA parlance) authorized since 2015, FDA summaries for 14 lacked data on the ...
Three specific Power Stick antiperspirant varieties are being recalled nationwide after failing to meet safety manufacturing ...
The FDA noted that a key principle in developing guidance for early AD therapies is that treatment "must begin before there are overt clinical symptoms." "We enthusiastically support this idea ...
The FDA’s new draft guidance comes on the heels of a reflection paper from the European Medicines Agency on the use of AI in the drug product lifecycle, finalized in September 2024.
Some results have been hidden because they may be inaccessible to you
Show inaccessible results