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- FDA’s 505(b)(2) pathway offers faster, cheaper drug development and commercial gainsThe FDA’s 505(b)(2) regulatory route lets drug sponsors build on existing safety and efficacy data while proposing meaningful changes to a known product. By leveraging prior findings, companies can…
- Broad Institute partners with Boston Children’s Hospital and Jackson Lab to launch Center for Therapeutic Genetics for rare diseasesThe Broad Institute of MIT and Harvard announced a partnership with Boston Children’s Hospital and the Jackson Laboratory to create a Center for Therapeutic Genetics focused on rare diseases. The…