FDA unveils nine drugs getting streamlined reviews

Axios – Thursday, October 16, 2025
By Peter Sullivan

The Food and Drug Administration on Thursday selected nine drugs for expedited reviews intended to speed up the approval process.

Why it matters: The awarding of the new priority review vouchers is a key focus of FDA commissioner Marty Makary, who has called for shaking up how the agency handles drug approvals that can take up to a year.

Driving the news: The nine treatments that could be evaluated in one to two months under the streamlined process include products for Type 1 diabetes, nicotine vaping addiction, blindness and pancreatic cancer.

Between the lines: The moves upend the way FDA customarily does business, because regulators are proactively identifying drug candidates instead of waiting for manufacturers to submit voucher applications.

• “We are not taking a receive-only mode,” Makary said on a podcast posted Thursday on his X account. “We are going into the [FDA] divisions asking them tell us what you think is potentially amazing … and then let’s reach out to the companies.”
• One of the criteria for receiving the vouchers is affordability — an area that has not normally been in the FDA’s purview. The agency customarily focuses on a candidate drug’s safety and efficacy.
• The agency is also seeking to use the vouchers to boost U.S. manufacturing, as well as address a “large unmet medical need.”
• Some of the products winning the vouchers are already FDA-approved, meaning the priority review is only for approval of a new use.

What they’re saying: “We’ve got to try new things, we have to innovate, we have to be creative, we have to do things differently,” Makary said.

One of the drugs is the combination fertility treatment Pergoveris from EMD Serono, which was part of the Trump administration’s announcement Thursday on in-vitro fertilization.

The others are:

• Teplizumab, an already approved antibody from Provention Bio for Type I diabetes.
• Cytisinicline from Achieve Life Sciences for nicotine vaping addiction.
• DB-OTO from Regeneron for deafness.
• Cenegermin-bkbj from Dompé for blindness.
• RMC-6236 from Revolution Medicines for pancreatic cancer.
• Bitopertin from Disc Medicine for porphyria
• Ketamine from Phlow, the anesthetic that’s been used as a psychedelic treatment, for U.S. manufacturing.
• Augmentin XR from USAntibiotics for domestic manufacturing of a common antibiotic

Makary said more voucher awardees would be announced in a “couple weeks.”

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