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- Recon: FDA adcomm votes against Capricor’s DMD drug; Cytokinetics gets UK approval, NICE backing for heart drugWelcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.raps · 1d ago↗ source
- Euro Roundup: EFPIA pushes for shorter trial approval times in EU Biotech ActEFPIA has called for lawmakers to go beyond the reductions in clinical trial approval times proposed in the Biotech Act.raps · 1d ago↗ source
- FDA updates product-specific guidelines for injectable peptidesThe US Food and Drug Administration (FDA) has updated 17 draft product-specific guidances (PSGs) to assist sponsors in submitting abbreviated new drug applications (ANDAs) for injectable peptide pr…