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US FDA announces recipients of national priority vouchers
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US FDA announces recipients of national priority vouchers
Oct 16, 2025 3:54 PM

By Sneha S K

Oct 16 (Reuters) - The U.S. Food and Drug Administration

on Thursday announced the names of nine products, under a new

fast-track review process, which could potentially get approval

within one to two months of filing a complete application.

The regulator said it has selected Merck KGaA's

fertility drug Pergoveris, Sanofi's Type 1 diabetes

drug teplizumab, Regeneron's DB-OTO for deafness and

ketamine for domestic manufacturing of a general anesthetic.

These will have shorter review times compared to the typical

timeline of about 10-12 months.

The FDA's list also includes Revolution Medicines' ( RVMD )

RMC-6236 for pancreatic cancer, Disc Medicine's ( IRON )

bitopertin for porphyria, Achieve Life Sciences' cytisinicline

for nicotine vaping addiction as well as Dompe's cenegermin-bkbj

for blindness and augmentin XR for domestic manufacturing of a

common antibiotic.

Shares of Revolution rose 7.4%, while Disc Medicine ( IRON ) rose 19%

in extended trading.

The FDA in June launched the new Commissioner's National

Priority Voucher pilot program under which it could issue

vouchers to companies aligned with major national priorities,

such as meeting a large unmet medical need, reducing downstream

health care utilization, or addressing a public health crisis.

The new program will convene experts from the regulator's

offices for a team-based review, instead of using the standard

review system, where a drug application is sent to numerous FDA

offices.

Each drug review division within the FDA has been charged

with nominating a product while companies can also apply and

have their request reviewed, the FDA said on Thursday.

The agency expects to announce another group of products

under the new program in the coming months.

Eli Lilly's ( LLY ) experimental weight-loss pill,

orforglipron, could be fast-tracked under the new voucher

process, analysts had speculated last month. The FDA's list on

Thursday did not include orforglipron.

Lilly called the program a promising initiative adding,

"while it's too early to discuss how this submission pathway

might relate to any of our specific programs, we look forward to

learning more from the Administration," the company said in an

emailed response.

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