The ra­di­oli­gand field is on the cusp of a ma­jor com­pet­i­tive mo­ment, as a ri­val looks to bring the first gener­ic to a mar­ket that’s been dom­i­nat­ed by No­var­tis.

Ra­di­oli­gand ther­a­py aims to bring the cell-dam­ag­ing ef­fects of ra­di­a­tion di­rect­ly to the tu­mor site while min­i­miz­ing dam­age to sur­round­ing healthy cells. No­var­tis com­pares the drugs to a “smart key” that on­ly de­liv­ers a ra­dioac­tive pay­load once it fits in­to a “lock” found on can­cer cells.

Over the last decade, No­var­tis has turned ra­di­oli­gand ther­a­py in­to a multi­bil­lion-dol­lar fran­chise. It hasn’t been easy: The drugs’ short half-lives, com­plex man­u­fac­tur­ing process, and sup­ply chain re­quire­ments make them chal­leng­ing to ef­fec­tive­ly pro­duce and dis­trib­ute. But what was once a niche field has gained mo­men­tum, with more than 400 clin­i­cal tri­als reg­is­tered, and oth­er ma­jor phar­ma com­pa­nies have made sig­nif­i­cant in­vest­ments.

Re­gen­eron has won the first ever FDA ap­proval for a gene ther­a­py to treat a rare type of in­her­it­ed hear­ing loss, and the com­pa­ny plans to of­fer the treat­ment for free in the US, though that does not in­clude the cost of ad­min­is­tra­tion.

That treat­ment, which will be mar­ket­ed un­der the name Otar­meni, was one of the first to re­ceive a Com­mis­sion­er’s Na­tion­al Pri­or­i­ty Vouch­er from the FDA in Oc­to­ber 2025. It is de­signed to treat a form of hear­ing loss caused by mu­ta­tions to a key gene called otofer­lin.

It is the first gene ther­a­py to be ap­proved un­der the FDA’s CN­PV pro­gram, and the sixth treat­ment over­all to win ap­proval as part of the Trump ad­min­is­tra­tion pro­gram meant to speed drugs to mar­ket.

Tem­pero Bio, a drug de­vel­op­er that had big am­bi­tions to shake up the treat­ment of sub­stance use dis­or­ders, is wind­ing down op­er­a­tions, End­points News has learned.

The shut­down comes af­ter a "se­ri­ous ad­verse event" in an al­co­hol use dis­or­der tri­al of its lead drug, CEO Paul John­son told End­points in an emailed state­ment Thurs­day. John­son said the com­pa­ny is "not in a po­si­tion" to give fur­ther de­tails on what hap­pened.

The drug, called TMP-301, was Phase 2, place­bo-con­trolled tri­al in adults with al­co­hol use dis­or­der. Tem­pero halt­ed de­vel­op­ment of the drug in No­vem­ber but has now ful­ly ter­mi­nat­ed the pro­gram. The drug, a mGluR5 mod­u­la­tor, was meant to tar­get re­cep­tors in the brain that are thought to be core to ad­dic­tion.

MA­HA’s sway over HHS could face a fresh test now that Pres­i­dent Trump has a new pick for CDC di­rec­tor: Er­i­ca Schwartz, a for­mer deputy sur­geon gen­er­al.

The po­si­tion has been emp­ty since Au­gust, when Su­san Monarez was oust­ed af­ter clash­es with HHS Sec­re­tary Robert F. Kennedy Jr. Like Monarez, Schwartz is a more tra­di­tion­al pub­lic health choice, with a track record of sup­port­ing vac­ci­na­tion. But a cru­cial ques­tion will be just how much in­de­pen­dence she has from Kennedy's in­flu­ence and agen­da on im­mu­niza­tion.

To­mor­row on Post-Hoc Live at 11 a.m. ET, we’ve got a crossover episode! We'll be joined by Why Should I Trust You? host Brin­da Ad­hikari, whose show takes a look at the MA­HA move­ment and chang­ing trust in pub­lic health. Ad­hikari will be chat­ting with me and End­points’ MA­HA ex­pert Max Bay­er to talk about how Schwartz could sta­bi­lize a tur­bu­lent CDC and what the pick says about MA­HA's stand­ing in Trump­world.