Endpoints News
Elevar scores first FDA approval Read in browser
Endpoints News
Thank you for reading, dupa dupackia!
basic
UPGRADE
M T W Thu F
24 September, 2026
Endpoints 11 - Virtual Experience
September 28: Don Ingber of the Wyss Institute joins our Endpoints 11 virtual day for a fireside chat, alongside interviews with the honorees and gala highlights. Open to everyone, free to join. Register now.
presented by natera
The Miss­ing Lay­er in On­col­o­gy Re­al-World Da­ta
top stories
1. FDA nominee Overton backs swifter trials, dodges calls to rebuke Trump if needed
2. Elevar wins first FDA approval with second-line drug for bile duct cancer
3. FDA approves Eli Lilly's once-weekly insulin pen, setting up rivalry with Novo
4. Kyverna says long-term data bolster FDA submission for rare autoimmune CAR-T
5. Merck’s return to ophthalmology snags first success
6. Acadia drug fails mid-stage study in Alzheimer's psychosis, leading to modified Phase 3
more stories
• 
Max Bayer
.

If you were hoping for Heidi Overton to veer off course in her Senate confirmation hearing, you're out of luck. The new nominee to lead the FDA largely stuck to the script. Read my recap here.

My guess: She'll be confirmed. Sen. Bill Cassidy (R-LA), despite grilling her about her independence from the president, applauded her conduct at the end of the hearing. In a moment in which boring is good, it didn't appear that she ruffled any new feathers.
.
Max Bayer
Senior Reporter, Endpoints News
FDA commissioner nominee Heidi Overton testifies in front of the Senate HELP Committee in Washington, DC on Tuesday, Sept. 24, 2026. (Tom Williams/AP Images)
1
by Max Bayer

Hei­di Over­ton’s con­fir­ma­tion hear­ing to lead the FDA as com­mis­sion­er con­clud­ed af­ter a tense but large­ly re­spect­ful two hours of grilling from Sen­ate HELP Com­mit­tee...

Read the full story
2
by Zachary Brennan

The FDA ap­proved El­e­var Ther­a­peu­tics’ Lyr­fig­tu as a sec­ond-line treat­ment op­tion for cer­tain pa­tients with bile duct can­cer, which is di­ag­nosed in about 8,000 Amer­i­cans...

Read the full story
3
by Nicole DeFeudis

Eli Lil­ly’s once-week­ly basal in­sulin shot On­swik has been ap­proved by the FDA for pa­tients with type 2 di­a­betes.

Lil­ly has tout­ed On­swik as a...

Read the full story
Grand River Aseptic Manufacturing
Beyond Capacity and Cost: Strategic Decisions in Fill-Finish CDMO Partnerships
4
by Nicole DeFeudis

Kyver­na Ther­a­peu­tics tout­ed pos­i­tive one-year re­sults on Thurs­day in pa­tients with a rare au­toim­mune dis­or­der called stiff per­son syn­drome.

The con­di­tion af­fects about 6,000 pa­tients...

Read the full story
5
by Kyle LaHucik

Mer­ck’s $1.3 bil­lion up­front bet on Eye­Bioin 2024 is start­ing to pay off with an ef­fi­ca­cy win, though an­a­lysts ques­tioned safe­ty re­sults from a...

Read the full story
6
by Max Gelman

Aca­dia Phar­ma­ceu­ti­cals re­port­eda Phase 2 fail­ure in Alzheimer’s dis­ease psy­chosis, but the com­pa­ny said it saw enough sig­nal to con­tin­ue for­ward in­to Phase 3...