The FDA's in­ves­ti­ga­tion of Covid-19 vac­cine safe­ty in chil­dren has ex­pand­ed in­to adults, ac­cord­ing to peo­ple fa­mil­iar with the agen­cy's work — a sig­nif­i­cant widen­ing of scope amid the Trump ad­min­is­tra­tion's plans to re­think US vac­cine pol­i­cy.

The ex­pand­ed probe is be­ing led by Tra­cy Beth Høeg, a long­time skep­tic of the shots who on Mon­day will of­fi­cial­ly take over as act­ing di­rec­tor of the FDA's Cen­ter for Drug Eval­u­a­tion and Re­search.

Høeg has been lead­ing a re­ex­am­i­na­tion of side ef­fect re­ports for chil­dren that claims to have un­cov­ered 10 or more deaths, an as­sess­ment that has gen­er­at­ed dis­agree­ment and con­tro­ver­sy from in­side and out­side the FDA. That as­sess­ment has still not been re­leased by the agency, de­spite the fact that — if ac­cu­rate — it would seem to rep­re­sent an ur­gent safe­ty is­sue.

OR­LAN­DO, Fla. — Clin­i­cal tri­als in mul­ti­ple myelo­ma con­tin­ue to rapid­ly progress, and nowhere was this more ap­par­ent than at the Amer­i­can So­ci­ety of Hema­tol­ogy’s an­nu­al meet­ing. Com­pa­nies like John­son & John­son, Gilead and Ar­cel­lx were in Flori­da to present their da­ta.

Lead­ing the pack were da­ta for J&J’s Tec­vayli, a bis­pe­cif­ic an­ti­body tar­get­ing BC­MA and CD3. Re­sults from last month’s ab­stract showed that Tec­vayli, when com­bined with Darza­lex, an­oth­er J&J an­ti­body, cut the risk of dis­ease pro­gres­sion or death by 83% com­pared to stan­dard Darza­lex reg­i­mens.

On over­all sur­vival, the Tec­vayli com­bi­na­tion cut the risk of death by 54%. Pa­tients in­clud­ed in the study, called Ma­jesTEC-3, pre­vi­ous­ly tried one to three pri­or treat­ment reg­i­mens.

The FDA is re­ex­am­in­ing the safe­ty of two ap­proved RSV an­ti­bod­ies for in­fants, the lat­est move by the agency to scru­ti­nize ap­proved pre­ven­tive prod­ucts used in chil­dren.

The FDA spoke with drug­mak­ers last week, in­form­ing As­traZeneca, Mer­ck and Sanofi that it would take an­oth­er look at the safe­ty of their prod­ucts, ac­cord­ing to a source fa­mil­iar with the ses­sion, who de­scribed it on con­di­tion of anonymi­ty. A spokesper­son for Mer­ck con­firmed the com­pa­ny had a meet­ing with the FDA on the is­sue.

The FDA's Cen­ter for Drug Eval­u­a­tion and Re­search “is rig­or­ous­ly re­view­ing the avail­able da­ta, as it does for all prod­ucts, to en­sure de­ci­sions re­main root­ed in ev­i­dence-based sci­ence and in the best in­ter­est of pa­tients,” HHS spokesper­son An­drew Nixon said in a state­ment. Reuters re­port­ed news of the re­view ear­li­er Tues­day.

As cell and gene ther­a­pies with high price tags be­come more preva­lent, a new start­up is aim­ing to help em­ploy­ers and health plans nav­i­gate those costs in a more pre­dictable way.

The New York-based start­up, Ar­a­digm, raised $20 mil­lion, the com­pa­ny told End­points News ex­clu­sive­ly. Frist Cressey Ven­tures led the Se­ries A round, and An­dreessen Horowitz and Mor­gan Health al­so par­tic­i­pat­ed. Ar­a­digm raised a $5 mil­lion seed round led by An­dreessen Horowitz in 2024.

Will Shrank, CEO and co-founder of Ar­a­digm, said there’s an in­flec­tion point hap­pen­ing with cell and gene ther­a­pies as mul­ti-mil­lion dol­lar treat­ments for ge­net­ic dis­or­ders, as well as high-cost cell ther­a­pies like CAR-T for can­cer, be­come more com­mon. Plan­ning for that ex­pense as an em­ploy­er or health plan can be a chal­lenge.