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- 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

Sanofi/Regeneron wins another EU approval for Dupixent

Becomes first biologic approved in EU for CRSwNP indication

Roche Basel Switzerland

US, EU regulators start review of Roche’s Soliris rival satralizumab

Sets up a possible market clash with Alexion next year

Roche Basel Switzerland

Roche moving closer to approval of Spark takeover; report

Antitrust authorities in both US and UK look likely to end delay

- PMLiVE

Vertex scores FDA approval for CF triple therapy Trikafta

Decision comes only a few months after therapy was filed

- PMLiVE

Seattle Genetics preps filing next year for oral HER2 drug

Company has positive phase 3 data to support filings

- PMLiVE

Roche eyes filings for Tecentriq/Avastin combo in liver cancer

Another important milestone for Roche's Tecentriq plans

Roche Basel Switzerland

Roche scores another FDA approval for Xofluza

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

Roche Basel Switzerland

Roche reports continued growth in Q3, despite biosimilar competition

Spark acquisition expected to complete this year

- 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

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