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FDA Finally Approves Avastin In First-Line Ovarian Cancer

 
• By Emily Hayes

Genentech says it worked closely with the agency to bring the drug to women with earlier-stage disease.

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Eight years after pivotal data were presented publicly supporting its use in first-line advanced ovarian cancer after surgery, Roche's VEGF inhibitor Avastin finally has been approved by the US FDA for this indication.

The June 13 approval covers treatment with Avastin (bevacizumab) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin as...

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Kisunla Back In The Spotlight As EMA Reconsiders Alzheimer’s Drug Rejection

 
• By Eliza Slawther

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Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary Says

 
• By Sue Sutter

The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.

EU Decision Time For Madrigal’s MASH Drug Resmetirom And 11 Others

 
• By Eliza Slawther

Madrigal Pharmaceuticals’ resmetirom could become the first approved treatment for non-cirrhotic metabolic dysfunction-associated steatohepatitis in the EU, if the European Medicines Agency issues a positive opinion for the drug later this week.