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- PMLiVE

pre-exposure prophylaxis (PrEP)

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Amarin wins FDA advisory nod for Vascepa cardiovascular expansion

Approval likely for fish-oil derived drug following speedy review

Novartis day

Novartis makes case for NASH candidate tropifexor

Race to market intensifies as rivals strive to win first-in-class

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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

- PMLiVE

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

- PMLiVE

Gilead promotes Andrew Dickinson to CFO, increased M&A expected

Dickinson helmed company’s acquisition of Kite and partnership with Galapagos

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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 poaches Genentech-exec Merdad Parsey for its new CMO

Company also files potential blockbuster filgotinib in Japan

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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

- PMLiVE

Arbutus hit hard as new hep B drug fails on safety

Shares have fallen sharply since company reported results

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