The news: The FDA will now make a single clinical trial—rather than two—the default standard for drug approvals. The change, first discussed by FDA chief Marty Makary in December, is intended to speed new drugs to market.

Why it matters: While single-study approvals are already common in certain rare or serious diseases—66% of the 50 drugs approved in 2024 relied on one pivotal trial, per AgencyIQ analysis—the new policy expands that flexibility to more common conditions that previously required two trials.

At the same time, the agency has taken a tougher posture toward vaccines and emerging technologies like mRNA and some gene therapies. Earlier this month, Moderna’s mRNA flu vaccine received a rare refusal-to-review decision—only seen in about 4% of submissions—before the FDA reversed course amid internal and industry pushback.

The result isn’t more across-the-board flexibility, but rather a split approach of streamlined reviews for some drugs and stricter oversight for others.

Implications for pharma and biotech companies: The change creates a more divided regulatory landscape that now allows drugs for common conditions to move faster and cost less to develop, while vaccines and newer technologies like mRNA face closer scrutiny. The split will shape where companies invest, how they design clinical studies, and how investors consider risk across different types of treatments.

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