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- 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 · 10d ago↗ source
- STAT+: Nabla’s new CEO on plan to gain market share in a competitive AI scribe environmentAmbient scribe developer Nabla said Brian Manning will be the Paris-based company's new CEO as it looks to grow in a highly competitive market.STAT · 10d 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…