FDAadcomms

FR public inspection notice public-inspection.federalregister.gov/2026-04497.pdf

Upcoming FDA advisory committee Apr 30 Morning: $AZ camizestrant NDA for HR+/HER2- metastatic breast cancer w/ ESR1 mutation (in combo w/ CDK4/6 inhibitor). Afternoon: $AZ capivasertib (Truqap) sNDA w/ abiraterone for PTEN-deficient metastatic hormone-sensitive prostate cancer

This Thursday an FDA advisory committee will discuss Generative Artificial Intelligence-Enabled Digital Mental Health Medical Devices Meeting materials: #event-materials" target="_blank" rel="nofollow noopener">fda.gov/advisory-commi…

Oct 9 #VRBPAC

Nov 6 adcomm public-inspection.federalregister.gov/2025-17651.pdf

Vote 10-1 against

FDA posts documents ahead of Friday's advisory committee meeting for Otsuka's Rexulti (brexpiprazole), which is proposed to treat #PTSD, in combination with Zoloft (sertraline) #event-materials" target="_blank" rel="nofollow noopener">fda.gov/advisory-commi…

Vote 6-1 against

FDA has posted meeting materials for Thursday's adcomm for $GSK's belantamab mafodotin #event-materials" target="_blank" rel="nofollow noopener">fda.gov/advisory-commi…

FDA schedules Jul 17 adcomm for $GSK's belantamab mafodotin. Details in pic.

On July 18, the FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) will vote on whether to support Rexulti (brexpiprazole) for PTSD. Here’s what the data says—and why approval odds are stuck at 50/50. 🧵

Link: fda.gov/advisory-commi…

FDA posts meeting materials for tomorrow's FDA Pediatric Advisory Committee. The committee will conduct routine pediatric safety reviews required under BPCA, PREA and PMDSIA.

Full company PR: capricor.com/investors/news…

$CAPR adcomm update: "As part of the FDA’s ongoing review, the Company has been informed that an Advisory Committee meeting is not indicated at this time."

FDA has withdrawn the federal register public inspection notice that was made yesterday for this meeting. The withdrawal notice can be requested via email to fr.inspection@nara.gov

Federal register public inspection notice public-inspection.federalregister.gov/2025-10989.pdf

FDA schedules July 18 adcomm for Otsuka's REXULTI (brexpriprazole) for PTSD in combination with sertraline.

FR public inspection notice public-inspection.federalregister.gov/2025-10855.pdf