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28 July, 2026 |
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Investors hammered Capricor and Replimune this week as FDA staffers once again pooh-poohed their drugs ahead of adcomms. We never know how advisors will vote, but as Max Bayer explains, it's a good lesson that the FDA allowing a resubmission doesn't mean it's had a change of heart. |
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Kevin Miller |
Deputy Editor, Endpoints News
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by Max Bayer
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Two days, two similar briefing documents and two companies with diving share prices. The FDA this week laid out its concerns with clinical data from... | |
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by Nicole DeFeudis
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After more than a decade and three failed bankruptcy attempts, an end to Johnson & Johnson’s talc saga may finally be in sight. The company... | |
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by Zachary Brennan
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The FDA revised its draft guidance for generic companies looking to develop copycats of some of the world's best-selling weight loss drugs, including Eli Lilly's... | |
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by Max Gelman
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Alnylam is one of biopharma’s biggest mysteries so far in 2026. The broader market is seeing a resurgence after years of a bearish environment. M&A... | |
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by Ayisha Sharma
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Just a little over six months into his tenure as CEO at GSK, Luke Miels is making his mark. The drugmaker on Tuesday outlined plans... | |
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