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Keeping Track: Immuno-Oncology Racks Up More Approvals; Bar Still Too High For Advair Generics

 
• By Bridget Silverman

The latest drug development news and highlights from our US FDA Performance Tracker.

Keeping Track Feature image

Immuno-Oncology was yet again the center of action at FDA, as Merck KGAA and Pfizer Inc.'s Bavencio became the latest PD-1/L1 inhibitor with a bladder cancer indication and Merck & Co. Inc.'s Keytruda received the agency's first approval of an IO/chemotherapy combination.

The failure of Roche's Tecentriq in a confirmatory trial for its accelerated approval second-line bladder cancer claim, however, cast a shadow over the seemingly inexorable progression of approvals

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More from Approvals

New EU Filings

 
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Mesoblast’s Ryoncil: US FDA Changed Its Mind On Need For A Randomized Trial

 
• By Sue Sutter

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Ryoncil Chronology: Three Review Cycles, Two CRLs, One Dispute Resolution Request

 
• By Sue Sutter

The Pink Sheet’s Drug Review Profile looks at the timeline for the clinical development and US FDA review of Mesoblast’s remestemcel for graft-versus-host disease.

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FDA Adcomms Are Back: Four Cancer Drugs, COVID-19 Vaccine Formulations To Get Reviews

 
• By Sue Sutter and Bridget Silverman

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Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 
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Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling

 
• By Sue Sutter

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