BridgeBio Pharma Announces Positive Feedback from the U.S. FDA and EU EMA on the Regulatory Path for a Pivotal Phase 3 Trial of Infigratinib in Children with Achondroplasia

<p>– BridgeBio completed an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), and a scientific advice engagement with the European Union (EU) European Medicines Agency (EMA) – FDA and EMA alignment was reached on the adequacy of a one-year, 2:1 randomized, placebo-controlled Phase 3 pivotal trial for infigratinib to support a marketing […]</p>
<p>The post <a rel="nofollow" href="https://forextv.com/top-news/bridgebio-pharma-announces-positive-feedback-from-the-u-s-fda-and-eu-ema-on-the-regulatory-path-for-a-pivotal-phase-3-trial-of-infigratinib-in-children-with-achondroplasia/">BridgeBio Pharma Announces Positive Feedback from the U.S. FDA and EU EMA on the Regulatory Path for a Pivotal Phase 3 Trial of Infigratinib in Children with Achondroplasia</a> appeared first on <a rel="nofollow" href="https://forextv.com">ForexTV</a>.</p>