On October 17, 2025, the United States Food and Drug Administration (FDA) announced on Thursday, October 16, that nine products will be eligible for its newly established expedited review program, with the potential for approval within one to two months after submitting a complete application.
The nine products include Merck KGaA’s fertility drug Pergoveris, Sanofi’s type 1 diabetes drug Teplizumab, Regeneron’s hearing loss treatment drug DB-OTO, and ketamine used for the domestic production of general anesthetics, among others.
The list also includes Revolution Medicines’ drug RMC-6236 for treating pancreatic cancer, Disc Medicine’s drug Bitopertin for treating porphyria, Achieve Life Sciences’ drug Cytisinicline for treating nicotine e-cigarette addiction, Dompe’s drug Cenegermin-bkbj for treating blindness, and domestically produced common antibiotic Augmentin XR.
Compared to the usual review period of about 10-12 months, these products will undergo review in a shorter timeframe.
Following the release of the list, Revolution’s stock price rose by 7.4% in after-hours trading, while Disc Medicine surged by 19%.
In June, the new FDA Commissioner initiated the National Priority Voucher pilot program, which issues priority review vouchers to companies that align with national priorities. This is to meet unmet medical needs on a large scale, reduce downstream healthcare resource consumption, or address public health crises.
The pilot program assembles a team of expert reviewers from the regulatory agency’s office to conduct collective evaluations, replacing the standard review system of submitting drug applications to multiple FDA offices.
On Thursday, the FDA stated that all drug review divisions within the agency are required to nominate products, and companies can also proactively apply and undergo review.
The agency expects to release another list of products under the new program in the coming months.
Analysts speculated last month that Eli Lilly’s experimental weight-loss drug Orforglipron could potentially undergo expedited review through the new voucher program.
Eli Lilly praised the broad prospects of the program in an email, stating, “We look forward to obtaining more information from government authorities, and it’s premature to discuss specific plans at this stage.”
(This article was referenced from a report by Reuters)