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Keeping Track: Oncology Submissions From Blueprint, Y-mAbs, BMS/bluebird; Approvals For BMS’ Reblozyl, LFB’s SevenFact

 
• By Bridget Silverman

The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker.

Keeping Track Feature image

Oncology products took center stage last week, thanks to submissions for Blueprint Medicines Corp.’s targeted therapy pralsetinib, Y-mAbs’ antibody therapeutic naxitamab, bluebird bio Inc. and Bristol-Myers Squibb Co.’s CAR-T immunotherapy idecabtagene vicleucel, and, for the second time, Aveo Pharmaceuticals Inc.’s targeted therapy tivozanib.

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AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

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US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
• By Bridget Silverman

Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.

‘Pipeline In A Pill’ Or Pipe Dream? US FDA’s April Goal Dates Test Expansion Strategies

 
• By Bridget Silverman

Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.

US FDA’s March Approval Candidates Take Aim At Established Markets

 
• By Bridget Silverman

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