Events Food and Drug Administration Medical science Safety 
European Pharmaceutical Review
DECEMBER 28, 2023
We received encouraging feedback from the US Food and Drug Administration (FDA) on the trial design and potential for accelerated approval. These efficacy results, combined with the safety profile that allows patients to complete their treatment regimen, are extremely encouraging.
European Pharmaceutical Review
FEBRUARY 22, 2023
Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. When the balloon reaches a sufficient pressure, this pushes the dissolvable needle into the intestinal wall, delivering the drug payload.” No serious adverse events were reported.
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