US FDA’s April Outlook: Decisions Pending For Rare Pediatric Diseases, New Antibiotics

 
• By Bridget Silverman

User fee goal dates in April include four novel agents with breakthrough therapy designations, including Pfizer’s hemophilia B gene therapy and Immunity Bio’s IL-15 superagonist complex for bladder cancer.

fresh-branches-of-a-bud-and-young-leaves-with-raindrops
There are not a deluge of NMEs that could be approved in April, but they offer green shoots nonetheless. • Source: Shutterstock

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