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- Spruce’s successful FDA talks plant seeds for Q4 filing of ultra-rare disease drugSpruce Biosciences has taken another step toward filing for FDA approval of its ultra-rare disease drug candidate, ticking off some of the manufacturing tasks needed to submit the long-awaited appl…Fierce Biotech · 9h ago↗ source
- STAT+: Inside Moderna and Merck’s cancer vaccine triumphModerna and Merck's wild gambit on a cancer vaccine appears to have worked, despite big doubts, logistical challenges, and pandemic-era complications.STAT · 10h ago↗ source
- Regenxbio gene therapy refiling plan derailed by FDA hold over spine MRI findingsThe FDA has put a clinical hold on Regenxbio’s RGX-121 over asymptomatic spine MRI findings, derailing the biotech’s plans to refile for approval of the once-rejected gene therapy candidate.