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FDA to decide on future of Sarepta's exon-skipping drugs Read in browser
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30 June, 2026
Manufacturing Day 2026
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1. Abivax aims to set cancer concerns with ulcerative colitis drug to rest
2. Unicycive gets second CRL for kidney drug as manufacturing woes continue
3.
news briefing
Sarepta's FDA decision date; Flare gets Anna Protopapas as CEO
4. Exclusive: House China panel questions Bristol Myers, Pfizer on trial sites
5. NEJM retracts pivotal data for Amgen's Tavneos
6. Sanofi’s Pompe disease treatment successor passes Phase 3 test in babies
7. BeOne’s Brukinsa succeeds in frontline mantle cell lymphoma study
8. Beeline adds $126M to Bain-backed immunology pipeline from Bristol Myers
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Karen Weintraub
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It’s officially summer, so time we started choosing our Endpoints 11 awardees. We’d appreciate nominations of truly innovative private companies that deserve to make the list. We’ll honor them at an event in September and we’d love to see you there.

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Karen Weintraub
Deputy Editor, Endpoints News
Marc de Garidel, Abivax CEO
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by Elizabeth Cairns

Late on Mon­day, Abi­vax re­leased new tri­al da­ta on its ul­cer­a­tive col­i­tis can­di­date, show­ing that can­cer cas­es in a Phase 3 tri­al were with­in the...

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by Anna Brown

Uni­cy­cive Ther­a­peu­tics’ chron­ic kid­ney dis­ease drug was re­ject­ed by the FDA for a sec­ond time over per­sis­tent is­sues at a third-par­ty con­tract man­u­fac­tur­er.

The com­pa­ny’s...

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News Briefing: Quick hits from the biopharma web
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by ENDPOINTS

Plus news about Deer­field, In­flaRx, Prax­is, Nu­vec­tis, Pyx­is On­col­o­gy, Vista­gen, Ar­cutis Bio­ther­a­peu­tics and Nx­era.

🔎 FDA to de­cide on fu­ture of Sarep­ta ex­on-skip­ping drugs by...

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Rep. John Moolenaar (R-MI) (Lenin Nolly/Sipa USA/Sipa via AP Images)
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by Drew Armstrong

A con­gres­sion­al com­mit­tee has opened an in­quiry in­to Bris­tol My­ers Squibb and Pfiz­er's use of clin­i­cal tri­al sites in Chi­na, in­clud­ing fa­cil­i­ties that the com­mit­tee's...

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