The news: The rate of prescription drug approvals decreased while drug review delays and rejections increased in Q3, according to new analysis from RBC Capital Markets, reported by STAT.

Digging into the data: The FDA’s approval rate for new drugs dropped to 73%, down from an average of 87% in the previous six quarters, per STAT’s report.

• Missed review deadlines rose to 11%, up from an average of 4%.
• Rejected marketing applications increased to 15%, up from RBC’s calculated historical average of 10%, per STAT.

Why it matters: Review and approval delays can postpone drug launches, increase costs, and complicate marketing planning for pharma companies. The average time to develop and gain approval for a drug in the US is 10 to 15 years, per pharma trade group PhRMA, and costs about $1.3 billion, per a recent JAMA study.

Zooming out: The FDA debuted a new pilot program in June aimed at cutting drug approval timelines to one to two months, down from 10 to 12 months, after an application is filed.

• Last week, the agency announced it awarded nine initial priority vouchers.
• The FDA said it will name another group of recipients in the coming months.
• Expedited drug approvals could save up to $5 million in late-stage trial costs alone, per a 2023 Harvard Business School study.

Yes, and: To earn the new FDA vouchers, pharma companies must align with the Trump administration’s national health priorities, including addressing unmet public health needs, boosting US drug manufacturing, and delivering innovative cures.

Our take: Rising rejection rates and delays raise the bar for pharma companies. Drugmakers need to ensure complete, high-quality submissions that anticipate scrutiny and minimize risk. AI tools can help by flagging data gaps, predicting reviewer concerns, and making sure submissions meet current FDA standards.

At the same time, the FDA’s new priority voucher offers a new path forward. Pharma companies already investing in US manufacturing and public health, especially in areas like oncology and rare disease, should double down, since alignment with agency priorities could translate into meaningful time-to-market advantages.

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