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- FDA offers updated guidance for generics of weight loss blockbustersThe FDA revised its draft guidance for generic companies looking to develop copycats of some of the world's best-selling weight loss drugs, including Eli Lilly's Zepbound and Novo Nordisk's Ozempic…
- FDA staff say Replimune's melanoma trial failed to prove RP1 worksFDA staff threw cold water on Replimune’s advanced melanoma drug ahead of a critical meeting with agency advisors, writing that the pivotal study design failed to prove its drug actually works. The…