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Keeping Track: US FDA Approves Sickle Cell Therapy Endari; Array Submits Binimetinib Again

 
• By Bridget Silverman

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

Keeping Track Feature image

The US FDA did one big thing this week: the agency resolved concerns about the quality of the clinical data for Emmaus Life Sciences Inc.'s Endari with approval of the amino acid powder for sickle cell disease, highlighting the nearly 20-year drought in new therapies for the rare blood disorder.

FDA also refined the indication and labeling for Amgen Inc.'s Vectibix and granted a new indication to Bristol-Myers...

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