The FDA fi­nal­ly green­lit No­vo Nordisk’s once-week­ly in­sulin for type 2 di­a­betes, mak­ing it the first US-ap­proved longer-act­ing al­ter­na­tive to dai­ly basal treat­ment for this in­di­ca­tion.

The Thurs­day ap­proval of the 700 ml basal in­jec­tion gives adults with type 2 di­a­betes a more con­ve­nient op­tion, re­duc­ing the num­ber of in­jec­tions need­ed from sev­en to one. It will be sold as Aw­iqli and will be avail­able to US pa­tients in the com­ing months.

No­vo is the first to tap in­to this mar­ket, ahead of ri­val Eli Lil­ly's once-week­ly in­sulin in­jec­tion, called ef­si­to­ra. Lil­ly has said it planned to sub­mit ef­si­to­ra for the treat­ment of adults with type 2 di­a­betes to glob­al reg­u­la­to­ry agen­cies by the end of 2025.

Ot­su­ka is buy­ing neu­ropsy­chi­atric drug­mak­er Tran­scend Ther­a­peu­tics in a deal worth rough­ly $1.2 bil­lion, fur­ther bol­ster­ing a class of drugs that are sup­posed to pro­vide the ther­a­peu­tic ben­e­fits of psy­che­delics with­out the trip.

As part of the deal, an­nounced Fri­day, Ot­su­ka is pay­ing $700 mil­lion up­front and of­fer­ing more than $500 mil­lion in po­ten­tial mile­stone pay­ments. It is at least the sec­ond ma­jor ac­qui­si­tion of a com­pa­ny work­ing to de­vel­op non-hal­lu­cino­genic psy­choac­tive drugs in the last year, adding mo­men­tum to star­tups build­ing off decades of psy­che­del­ic re­search.

The drug that caught Ot­su­ka’s eye was methy­lone, or TSND-201. It's part of a broad­er group­ing of drugs called neu­ro­plas­to­gens that aim to heal or re­pair con­nec­tions be­tween neu­rons in the brain. New York-based Tran­scend is de­vel­op­ing methy­lone for a trio of men­tal health con­di­tions, with a lead pro­gram in PTSD. Last year, the biotech com­pa­ny un­veiled promis­ing Phase 2 da­ta that showed methy­lone may be com­pa­ra­ble to oth­er clin­i­cal-stage pro­grams at re­duc­ing PTSD symp­toms, name­ly Lykos Ther­a­peu­tics’ MD­MA-as­sist­ed ther­a­py.

The Eu­ro­pean Med­i­cines Agen­cy's hu­man med­i­cines com­mit­tee has rec­om­mend­ed the ap­proval of four new drugs and a new form of Sanofi’s mul­ti­ple myelo­ma drug.

CHMP gives its opin­ions on drug ap­provals and la­bel ex­pan­sions to the Eu­ro­pean Com­mis­sion. The Com­mis­sion has the fi­nal say but typ­i­cal­ly fol­lows CHMP’s rec­om­men­da­tions.

Sanofi on Fri­day got a pos­i­tive opin­ion for a sub­cu­ta­neous ad­min­stra­tion of Sar­clisa across all ap­proved in­di­ca­tions, along with a new phar­ma­ceu­ti­cal form, strength and so­lu­tion for in­jec­tion. If ap­proved, Sar­clisa would be­come the first an­ti­cancer drug to be ad­min­is­tered through an on-body in­jec­tor, Sanofi said in a Fri­day re­lease.

Cur­rent­ly, Sar­clisa can on­ly be ad­min­is­tered in­tra­venous­ly. CHM­P's opin­ion was based on Sanofi's RAK­LIA Phase 3 study, which showed the sub­cu­ta­neous form was not in­fe­ri­or to the in­tra­venous in­fu­sion.

→ Re­cur­sion has hired a new top doc­tor, bring­ing on Vic­ki Good­man as chief med­ical of­fi­cer. Good­man pre­vi­ous­ly served as CMO of the can­cer biotechs Ex­elix­is and Mur­al On­col­o­gy. She is tak­ing over for David Mau­ro, who has been in the role for near­ly three years. Good­man's hir­ing is one of the biggest ex­ec­u­tive changes since Na­jat Khan took over as CEO at the start of 2026.

→ Pablo Cagnoni’s job ti­tle at In­cyte has been mod­i­fied to pres­i­dent and glob­al head of R&D, while long­time CMO Steven Stein will add to his re­spon­si­bil­i­ties as head of late-stage de­vel­op­ment. CEO Bill Meury was­n't done, nam­ing J&J vet Mo­hamed Is­sa as head of US com­mer­cial. Is­sa had l