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- FDA updates guidance for generic makers of top GLP-1 weight-loss drugsThe FDA has released a revised draft guidance aimed at companies that want to develop generic versions of leading weight-loss medications. The update focuses on products such as Eli Lilly's Zepbou…
- FDA finds Replimune's melanoma data package uninterpretable, foreshadows tough advisory committee reviewThe FDA has deemed the single-arm mid-stage study submitted by Replimune for its oncolytic immunotherapy RP1 as not interpretable, raising concerns ahead of an upcoming advisory committee meeting.…