Import Safety Agreement Further Entwines FDA/China Regulatory Process
Chinese manufacturers of certain drugs or active pharmaceutical ingredients selected by FDA will have to meet new registration standards as part of a memorandum of understanding signed Dec. 11 in Beijing by HHS, FDA and China's State Food and Drug Administration
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Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.
Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.
