Celia Wit­ten, deputy di­rec­tor of the FDA's Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search, has left the FDA, adding to a wave of de­par­tures at the agency and across the fed­er­al health in­fra­struc­ture as Robert F. Kennedy Jr. takes con­trol of HHS.

CBER's or­ga­ni­za­tion­al chart, up­dat­ed on Fri­day, notes at least a dozen de­par­tures, and that for­mer FDA chief of staff Julie Tier­ney is the on­ly deputy di­rec­tor of CBER. Tier­ney told End­points that she's been deputy di­rec­tor since Dec. 2023 but she did not com­ment on Wit­ten's de­par­ture.

Wit­ten's de­par­ture comes af­ter a long ca­reer at FDA and amid an ex­o­dus of se­nior staff, in­clud­ing CDER Di­rec­tor Pa­trizia Cavaz­zoni and FDA's Prin­ci­pal Deputy Com­mis­sion­er Na­mand­jé Bum­pus, lead­ing to ques­tions of who will lead the agency mov­ing for­ward. Wit­ten, who wrote in an out-of-of­fice mes­sage, "I have left the FDA," al­so pre­vi­ous­ly served as FDA's di­rec­tor of the Of­fice of Cel­lu­lar, Tis­sue and Gene Ther­a­py.

The FDA said Fri­day that the short­age of semaglu­tide, the main in­gre­di­ent in No­vo Nordisk’s GLP-1 drugs Ozem­pic and We­govy, has been re­solved af­ter more than two years.

The move could hin­der com­pound­ing phar­ma­cies’ abil­i­ty to make large amounts of copies of the brand-name obe­si­ty and di­a­betes drugs, which is typ­i­cal­ly per­mit­ted on­ly when there’s a sup­ply short­age. Med spas and tele­health com­pa­nies such as Hims and Ro have cap­i­tal­ized on the op­por­tu­ni­ty to pro­vide com­pound­ed semaglu­tide, but the FDA and drug­mak­ers have warned that the shots aren't test­ed or ap­proved for safe­ty and ef­fi­ca­cy.

Him­s' stock dropped by as much as 20% on Fri­day morn­ing, while No­vo Nordisk’s stock was up about 4% on the news.

A fed­er­al judge in Mass­a­chu­setts ex­tend­ed a na­tion­wide block on the NIH’s 15% cap on in­di­rect cost re­im­burse­ments for grant re­cip­i­ents.

Tem­po­rary re­strain­ing or­ders are usu­al­ly in place for two weeks while a judge con­sid­ers the de­tails of a case. In a hear­ing on Fri­day, Judge An­gel Kel­ley de­ter­mined there was good cause to keep the or­der in place while she con­sid­ers whether to grant plain­tiffs’ re­quests for a pre­lim­i­nary in­junc­tion.

“I have a lot of work to do,” Kel­ley said dur­ing the hear­ing in the US Dis­trict Court for the Dis­trict of Mass­a­chu­setts. She said she would come to a de­ci­sion on the pre­lim­i­nary in­junc­tion as soon as pos­si­ble.

The FDA on Fri­day ap­proved Mirum Phar­ma­ceu­ti­cal­s' Ctexli to treat adults with cere­bro­tendi­nous xan­thomato­sis (CTX), a rare, pro­gres­sive and ge­net­ic dis­ease.

The ap­proval is based on the place­bo-con­trolled, Phase 3 RE­STORE study in 13 adult pa­tients, which met its pri­ma­ry end­point of re­duc­tion in bile al­co­hols and was high­ly sta­tis­ti­cal­ly sig­nif­i­cant, the com­pa­ny said.

The FDA not­ed the 24-week tri­al demon­strat­ed that the thrice-dai­ly pill re­sult­ed in a sig­nif­i­cant re­duc­tion in plas­ma cholestanol and urine 23S-pen­tol, which are cho­les­terol metabo­lites that are marked­ly in­creased in CTX pa­tients.

The FDA's ap­proval, which is a first for CTX, came more than a month be­fore its PDU­FA date.

Eli Lil­ly has amassed a stock­pile of soon-to-be-launched drugs and re­lat­ed ma­te­ri­als, pri­mar­i­ly its oral GLP-1 can­di­date or­for­glipron, worth more than half a bil­lion dol­lars. Or­for­glipron will be ready to roll out as soon as it se­cures reg­u­la­to­ry ap­proval, which could come in 2026.

“When we be­lieve that fu­ture com­mer­cial­iza­tion is prob­a­ble and the fu­ture eco­nom­ic ben­e­fit is ex­pect­ed to be re­al­ized, we cap­i­tal­ize pre-launch in­ven­