Thou­sands of FDA staff de­par­tures since April have sparked con­cerns with­in the phar­ma in­dus­try that nov­el drug ap­proval dead­lines might slip.

But in the first six months of 2025, the ap­proval num­bers re­main gen­er­al­ly aligned with pre­vi­ous years, even as FDA of­fi­cials warn that the full ex­tent of the staff cuts has yet to be re­al­ized.

As of Ju­ly 2, the FDA has ap­proved 24 new drugs and bi­o­log­ics so far in 2025, com­pared with 36 nov­el prod­ucts ap­proved by CDER and CBER over the same time pe­ri­od in 2024, and 40 in 2023. Ap­proval num­bers may vary year-to-year, de­pend­ing on pre­vi­ous years' sub­mis­sions, and of­ten serve more as a sign of in­dus­try pro­duc­tiv­i­ty and FDA's work­load.

Pres­i­dent Don­ald Trump said phar­ma­ceu­ti­cal com­pa­nies will have a grace pe­ri­od of at least a year to move their man­u­fac­tur­ing to the US be­fore fac­ing tar­iffs on their drugs.

The new de­tail dis­closed Tues­day by Trump came as he promised the tar­iffs on drug­mak­ers, which have been in de­vel­op­ment since ear­ly this year, would come "very soon." Trump has re­peat­ed­ly said over the last few months that the tar­iffs were com­ing short­ly.

A grace pe­ri­od would give com­pa­nies at least some time to shift man­u­fac­tur­ing — though it of­ten takes years to build and bring new drug plants on­line, far longer than Trump is propos­ing.

Sci­en­tists seek­ing to make per­son­al­ized gene edit­ing ther­a­pies a re­al­i­ty for more peo­ple have launched a new ini­tia­tive to de­vel­op cures for the rarest of dis­eases left be­hind by drug com­pa­nies.

The Cen­ter for Pe­di­atric CRISPR Cures, an­nounced Tues­day by the Chan Zucker­berg Ini­tia­tive, will make cus­tom treat­ments for chil­dren with in­her­it­ed im­mune con­di­tions or meta­bol­ic dis­eases. The cen­ter is part of the In­no­v­a­tive Ge­nomics In­sti­tute (IGI) at Uni­ver­si­ty of Cal­i­for­nia, Berke­ley and is sup­port­ed by a $20 mil­lion grant from the CZI.

The ef­fort builds on the re­cent suc­cess that sci­en­tists had in de­vel­op­ing a cus­tom CRISPR ther­a­py for one in­fant’s de­bil­i­tat­ing meta­bol­ic dis­ease in un­der sev­en months, Fy­o­dor Urnov, a gene edit­ing sci­en­tist at the IGI who is lead­ing the new cen­ter, told End­points News. He de­scribed that suc­cess as a “yes we can” mo­ment for the field.

An Ot­su­ka sub­sidiary said Tues­day that its ex­per­i­men­tal ther­a­py for Duchenne mus­cu­lar dy­s­tro­phy has failed its Phase 3 pri­ma­ry end­point in a group of am­bu­la­to­ry pa­tients in Japan.

Tai­ho Phar­ma­ceu­ti­cal said the study showed “no sig­nif­i­cant dif­fer­ence” over 52 weeks in pa­tients’ mean change from base­line in the time it takes to rise from the floor, miss­ing the pri­ma­ry end­point for a co­hort of pa­tients who can walk in­de­pen­dent­ly. Duchenne is a rare and dev­as­tat­ing ge­net­ic mus­cle dis­ease that pri­mar­i­ly af­fects boys and men.

The am­bu­la­to­ry co­hort en­rolled male Duchenne pa­tients 5 years and old­er who re­ceived ei­ther Tai­ho’s oral drug TAS-205 or a place­bo twice dai­ly for 52 weeks. Tai­ho hasn’t re­leased the full dataset, but said that “de­tailed re­sults” will be pre­sent­ed at a fu­ture aca­d­e­m­ic con­fer­ence. The com­pa­ny al­so set out to test TAS-205’s safe­ty in a non-am­bu­la­to­ry co­hort, ac­cord­ing to the US’ clin­i­cal tri­als reg­istry, but didn’t share in­for­ma­tion from that group on Tues­day.