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Keeping Track: US FDA Approves Koselugo, Bestows BTDs On Bavencio, Sotatercept

 
• By Bridget Silverman

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

Keeping Track Feature image

Breakthrough therapies provided the theme for US regulatory news in the past week. Two new breakthrough designations were announced, two breakthrough-designated products received FDA approval, and submissions were disclosed for two BTD products (one of them also a new BTD recipient).

The FDA also extended the user fee goal date by three months for Genentech Inc.’s risdiplam, which may not hold a BTD but is receiving priority review for treatment of spinal muscular atrophy

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Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

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

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

 
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EU CHMP Opinions And MAA Updates

 
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

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