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- FDA’s 505(b)(2) pathway offers faster, cheaper drug development and commercial gainsThe FDA’s 505(b)(2) regulatory route lets drug sponsors build on existing safety and efficacy data while proposing meaningful changes to a known product. By leveraging prior findings, companies can…
- Axiom Biosciences targets Hong Kong IPO to raise up to $200 million for regenerative therapy pipelineAxiom Biosciences, a San Diego‑based biotech, announced plans to list on the Hong Kong Stock Exchange rather than the traditional U.S. exchanges. The company aims to use the offering to secure new…