The FDA on Wednes­day ap­proved up­dat­ed for­mu­las of the Covid-19 vac­cines ahead of the fall res­pi­ra­to­ry sea­son, though the la­bels are more lim­it­ed than in years past.

Vac­cines were ap­proved for Pfiz­er, Mod­er­na and No­vavax for all adults 65 and old­er and peo­ple younger than 65 who are at high­er risk of se­vere dis­ease. Mod­er­na’s Spike­vax will be the on­ly shot avail­able for at-risk chil­dren 6 months to 5 years old af­ter the FDA pulled Pfiz­er's emer­gency use au­tho­riza­tion for Comir­naty in that age range.

Pfiz­er has yet to ask for ap­proval for the youngest kids, so its ap­proval la­bel ap­plies to peo­ple five years and old­er. No­vavax's vac­cine was ap­proved for kids and adults 12 and old­er.

HHS Sec­re­tary Robert F. Kennedy Jr. an­nounced the ap­provals in a post on X.

The FDA on Wednes­day kicked off a two-day meet­ing fo­cused on what's next for can­cer drug reg­istries, the of­ten messy de­pos­i­to­ries of raw pa­tient da­ta that are in­creas­ing­ly be­com­ing more use­ful in sup­port­ing ap­proval de­ci­sions.

FDA of­fi­cials opened the dis­cus­sion with some of the lim­i­ta­tions of reg­istries, de­pend­ing on their scope and de­sign, and oth­er ques­tions re­lat­ed to bias, da­ta het­ero­gene­ity, their rep­re­sen­ta­tion of the gen­er­al pa­tient pop­u­la­tion, and vary­ing da­ta qual­i­ty.

Even so, reg­istries have been used to sup­port new can­cer drug ap­provals. With the pro­lif­er­a­tion of more EHR and oth­er re­al-world hos­pi­tal and treat­ment da­ta, the FDA made clear that their use­ful­ness will like­ly progress.

Can­cer drug­mak­er Ex­elix­is is clos­ing its Philadel­phia-area lo­ca­tion and let­ting go of 130 peo­ple, a spokesper­son con­firmed to End­points News on Wednes­day.

Ex­elix­is opened the site in King of Prus­sia, PA in 2022 and had planned to add hun­dreds of em­ploy­ees there, ac­cord­ing to a re­port from the Philadel­phia Busi­ness Jour­nal that year.

It hired ex­ten­sive­ly dur­ing the pan­dem­ic and post-pan­dem­ic pe­ri­od to "meet the com­pa­ny's needs at the time," the spokesper­son said. But those needs have changed.

"We have made the dif­fi­cult de­ci­sion to re­or­ga­nize the com­pa­ny’s struc­ture to fo­cus large­ly on our op­er­a­tions in Alame­da, Cal­i­for­nia, and align the over­all team we have in place, in­clud­ing both Alame­da-based and re­mote em­ploy­ees, to de­liv­er on our mis­sion," the spokesper­son said.

In­di­v­ior said it is ex­e­cut­ing the first phase of a mul­ti­year re­struc­tur­ing plan to “max­i­mize the po­ten­tial” of its busi­ness, start­ing with lay­offs and re­al es­tate con­sol­i­da­tion.

The Vir­ginia-based biotech did not dis­close the num­ber of em­ploy­ees it plans to lay off. But the work­force cuts are ex­pect­ed to in­cur sev­er­ance-re­lat­ed charges of $16 mil­lion to $19 mil­lion, ac­cord­ing to an SEC fil­ing shared Tues­day. In­di­v­ior had 1,094 em­ploy­ees at the end of 2024, an an­nu­al re­port states.

The com­pa­ny al­so plans to back out of cer­tain re­al es­tate projects, which could in­cur fees of $15 mil­lion to $22 mil­lion. It al­so ex­pects to in­cur con­sult­ing, le­gal and tax plan­ning ex­pens­es of ap­prox­i­mate­ly $8 mil­lion to $9 mil­lion.

In to­tal, these ear­ly moves mean the com­pa­ny will have to spend be­tween $39 mil­lion to $50 mil­lion for the over­haul in the third and fourth quar­ters of this year.

BioX­cel is tak­ing the next step in an ef­fort to up­date the la­bel of its psy­chi­atric drug Igal­mi.

A Phase 3 tri­al study­ing Igal­mi en­rolled schiz­o­phre­nia or bipo­lar dis­or­der pa­tients who suf­fer episodes of ag­i­ta­tion. The com­pa­ny said ear­ly Wednes­day morn­ing that the drug suc­ceed­ed in show­ing it can be tak­en on an as-need­ed ba­sis at home.

The pri­ma­ry end­point was safe­ty and tol­er­a­bil­i­ty, and pa­tients were al­lowed to re­main on their oth­er an­tipsy­chot­ic drugs. (Igal­mi is a film placed un­der the tongue akin to a Lis­ter­ine strip.) Igalmi's pre­vi­ous ap­proval — in 2022 for the same in­di­ca­tion — on­ly al­lows it to be tak­en un­der the su­per­vi­sion of a doc­tor.