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- PMLiVE

Viaskin Peanut

- PMLiVE

Aveo’s tivozanib is knocked back by FDA once again

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

- PMLiVE

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

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

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

- PMLiVE

Gilead builds case for Descovy PrEP after FDA approval

Reported statistically significant improvements in kidney function

- PMLiVE

Gilead claims FDA okay for Descovy as second PrEP option

Can now push new indication before generics dent franchise

- PMLiVE

Sarepta rival NS Pharma files Duchenne drug with FDA

Another blow for Sarepta following FDA rejection earlier this year

- PMLiVE

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

Novartis building

Novartis points finger at AveXis execs in Zolgensma data scandal

Announces remediation plan including whistleblower scheme

- PMLiVE

Abeona Therapeutics’ rare disease phase 3 trial halted due to FDA concerns

Issues over transport stability must be resolved, says regulator

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