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China Stricter than U.S. in Cancer Drug Approvals: Study

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Chinese medical school researchers who analyzed cancer drug surrogate endpoint approvals in the U.S. and China say China appears t...

Address Heart Failure Patient-Reported Outcome Issues

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Researchers say some issues need to be resolved if patient-reported outcomes are to be used as a surrogate in heart failure drug a...

Recall All Humacyte Symvess Products: Petition

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Citing concerns raised by a vascular surgeon when he was a CDRH medical reviewer, Harmed Americans for Reform in Medical Device Sa...

FDA Clears Bright Uros Urodynamics Device

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FDA clears a Bright Uro 510(k) for its Glean Urodynamics System, a wireless, catheter-free ambulatory urodynamics device designed ...

Mirum Pharmaceuticals Livmarli Tablet Formulation OKd

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FDA approves Mirum Pharmaceuticals tablet formulation of Livmarli (maralixibat) for treating cholestatic pruritus.

TEST

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TEST

Ironwood Needs Another Apraglutide Trial: FDA

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Based on FDA recommendation, Ironwood Pharmaceuticals says it will conduct a new Phase 3 clinical trial for apraglutide for treati...

Pfizer Nixes Oral Weight Loss Drug Development

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Pfizer abandons the development of danuglipron, an experimental oral GLP-1 receptor agonist being evaluated for chronic weight man...

FDA Seizes Counterfeit Ozempic in Supply Chain

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FDA seizes several hundred units of counterfeit Ozempic (semaglutide) 1mg injection that had entered the U.S. drug supply chain.

Vanda Sues FDA to Allow Off-Label Promotion

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Vanda Pharmaceuticals sues FDA seeking a declaratory judgment giving the company protection under the First Amendment to promote H...