- The FDA’s 505(b)(2) pathway is an underestimated engine of value creationThe biopharma industry would do well to re-embrace the 505(b)(2) path, which allows sponsors to draw on previous findings around an existing drug even as they propose modifications to it.BioSpace · 3d ago↗ source
- Broad Institute launches Center for Therapeutic Genetics for rare diseasesThe Broad Institute of MIT and Harvard is teaming up with Boston Children’s Hospital and The Jackson Laboratory to launch a new center focused on genetic treatments for rare diseases, the triumvira…Endpoints · 3d ago↗ source
- Dyne gets early 2027 decision date for Duchenne therapy, analysts expect ‘smooth’ reviewIf approved, Dyne Therapeutics’ zeleciment rostudirsen could “capture the majority” of the exon-51 Duchenne muscular dystrophy market, given its better efficacy and dosing profile versus Sarepta Th…