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icosapent ethyl

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BeiGene bags FDA approval for first product Brukinsa in lymphoma

Also the first approval for a Chinese-developed cancer drug in US

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Amarin wins FDA advisory nod for Vascepa cardiovascular expansion

Approval likely for fish-oil derived drug following speedy review

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Aveo’s tivozanib is knocked back by FDA once again

Company says it will delay any regulatory filing until first quarter next year

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MD Anderson exec Stephen Hahn to be nominated FDA commissioner

US President Trump scouts well-known oncology expert to lead agency

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Vertex scores FDA approval for CF triple therapy Trikafta

Decision comes only a few months after therapy was filed

Roche Basel Switzerland

Roche scores another FDA approval for Xofluza

Expands use to patients at high risk of flu-related complications

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Novartis bags US okay for Lucentis follow-up Beovu in wet AMD

Head-to-head trial with rival Eylea could boost sales

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Gilead builds case for Descovy PrEP after FDA approval

Reported statistically significant improvements in kidney function

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Gilead claims FDA okay for Descovy as second PrEP option

Can now push new indication before generics dent franchise

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Sarepta rival NS Pharma files Duchenne drug with FDA

Another blow for Sarepta following FDA rejection earlier this year

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Acacia eyes February FDA verdict for refiled nausea drug Barhemsys

Back on track after being turned down twice

- PMLiVE

FDA approves Bavarian Nordic’s smallpox and monkeypox vaccine

First live non-replicating vaccine for both diseases

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