De­spite thou­sands of FDA staff cuts, re­tire­ments and lead­er­ship de­par­tures in 2025, the agency’s drug re­view­ers man­aged to hold the line and meet just about all of its user-fee com­mit­ments for new drug re­views.

On­ly two ap­pli­ca­tions took more than a year for FDA to re­view, af­ter the agency ac­cept­ed them as re­view­able, and both of those were ex­tend­ed to look at new da­ta, ac­cord­ing to an End­points News analy­sis of the sub­mis­sion and ap­proval dates for all 53 new drugs and bi­o­log­ics in 2025.

The FDA typ­i­cal­ly takes be­tween six and 10 months to re­view a new drug ap­pli­ca­tion, de­pend­ing on what ex­pe­dit­ed des­ig­na­tions a spon­sor re­ceives from the agency. More than 20 new drugs in 2025 had ap­pli­ca­tions grant­ed ap­proval in eight months or less, in­clud­ing those re­ceiv­ing pri­or­i­ty re­view, or fol­low­ing a re­sub­mis­sion from an ear­li­er re­jec­tion.

The fed­er­al gov­ern­ment like­ly won’t be able to over­turn a court or­der that blocked it from kick­ing off its 340B re­bate pi­lot, ap­peals judges ruled, deal­ing an­oth­er blow to drug­mak­ers that were poised to be­gin the pro­gram this month.

The US Court of Ap­peals for the First Cir­cuit de­nied HHS’ re­quest to sus­pend a low­er court’s pre­lim­i­nary in­junc­tion against the pi­lot pro­gram while it con­sid­ers the agency’s ap­peal.

The fed­er­al health agency failed to show that it is like­ly to suc­ceed on the mer­its of its ap­peal, the First Cir­cuit held late Wednes­day. HHS sub­mit­ted a “thread­bare” ad­min­is­tra­tive record void of ev­i­dence that it had con­sid­ered how the pro­gram would im­pact 340B-el­i­gi­ble hos­pi­tals, the judges said.

HHS de­clined to com­ment.

Sanofi said the FDA’s re­cent re­jec­tion of its po­ten­tial block­buster MS treat­ment was “un­ex­pect­ed” and that the agency raised ques­tions too late to make changes.

The com­pa­ny "ob­served evolv­ing per­spec­tives with­in the FDA re­view team with new con­sid­er­a­tions in­tro­duced late in the re­view cy­cle," a Sanofi spokesper­son told End­points News via email.

Af­ter mul­ti­ple, ear­li­er meet­ings with the agency, ques­tions "re­gard­ing pa­tient pop­u­la­tion de­f­i­n­i­tions emerged on­ly dur­ing the re­view, post study com­ple­tion, when ad­just­ments were no longer fea­si­ble," the spokesper­son said.

The FDA pub­lished the com­plete re­sponse let­ter this week for tole­bru­ti­nib, a BTK in­hibitor, in non-re­laps­ing sec­ondary pro­gres­sive MS in adults. In the let­ter, is­sued late last year, the reg­u­la­tor raised safe­ty ques­tions about the drug, as well as ques­tions about post-hoc analy­ses and its mech­a­nism of ac­tion.