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- STAT+: Regenxbio says Duchenne gene therapy succeeded in clinical trial, paving way for FDA submissionRegenxbio said its experimental gene therapy for Duchenne muscular dystrophy succeeded in a trial, paving the way for a submission to the FDA.STAT · 2mo ago↗ source
- BeOne’s next-gen BCL2 inhibitor wins FDA approval, taking aim at VenclextaBeOne Medicines has clinched an accelerated approval for its drug sonrotoclax in mantle cell lymphoma (MCL), marking the start of its bid to challenge AbbVie and Roche's Venclexta across a range of…Endpoints · 2mo ago↗ source
- STAT+: ‘No drama’ Diamantas should serve biotech well as acting FDA chiefKyle Diamantas, the acting commissioner of the FDA, is expected to be a drama-free, stabilizing caretaker at the top of the agency.