The FDA is changing dramatically, signaling a biotech comeback +1

▤ Summary

This article argues that recent FDA personnel changes and a new HHS plan are creating a more flexible approval environment for biotech drugs. It highlights Moderna as a beneficiary after the FDA reconsidered its vaccine application and its advisory committee delivered a unanimous positive vote. It also describes uniQure’s shifting regulatory path, where the FDA moved from demanding a Phase 3 trial to allowing a BLA submission through accelerated approval. The piece extends the same theme to Replimune and Regenxbio, then ties the broader regulatory shift to rising biotech valuations and a rebound in M&A activity.

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