FDAadcomms

Posting about FDA Advisory Committees (aka FDA AdComms)

[Jessica Adams @RxRegA]

Now that the vote is complete, I’ll ask the Designated Federal Officer to read the results from the screen.

[Biff #SARSisAirborne 🍉 @Biff234523]

📢 💉FDA vaccine committee recommends for updated 2026-2027 vaccines to target the XFG variant.

All three manufacturers have indicated preparedness to produce an XFG vaccine for fall release, and Sanofi has already started manufacturing of XFG Novavax/Nuvaxovid.

Link to today’s VRBPAC meting: https://t.co/zxmDlmhlGc

The vote was 8 Yes, 0 No, and 1 Abstain for the question “For the 2026-2027 Formula of COVID-19 vaccines in the U.S., does the committee recommend JN.1-lineage XFG variant as the preferred variant for an updated monovalent vaccine?”

Meeting slide decks:

• Sanofi: https://t.co/W4AcJ4JeV6

• Moderna: https://t.co/qWXp86DHkD

• Pfizer: https://t.co/PCdVPrtvVI

• CDC epidemiology and genomics: https://t.co/YzwgOjdgUi

• CDC vaccine effectiveness: https://t.co/Q2hiIUgqIj

• WHO TAG-CO-VAC: https://t.co/M1MdSFlyGy

• FDA strain selection: https://t.co/yvf3pZFKva

[FDAadcomms @FDAadcomms]

June 18th: FDA adcomm for Moderna's flu vaccine
https://t.co/j0LYUQJxLR

[Jessica Adams @RxRegA]

I have to admit nothing would make me happier than the restoration of FDA advisory committees.

[OncLive.com @OncLive]

BREAKING🚨: @US_FDA ODAC voted 6-3 that switching to camizestrant upon emergence of an ESR1 mutation during treatment with an aromatase inhibitor and a CDK4/6 inhibitor ahead of radiographic disease progression did not demonstrate clinically meaningful benefit for the treatment of patients with hormone receptor–positive, HER2-negative metastatic breast cancer.

Read more on the vote here: https://t.co/5fYIFKdfga

[OncLive.com @OncLive]

BREAKING: The FDA’s ODAC voted 7 to 1, with 1 abstention, that the benefit of adding capivasertib to abiraterone acetate did outweigh the risk in the treatment of patients with PTEN-deficient mHSPC #pcsm #oncology

Read more on the committee vote here: https://t.co/5KpAWbcCOL

[FDAadcomms @FDAadcomms]

@eperlste https://t.co/U0kvj1nZjF

[Jessica Adams @RxRegA]

If there’s no change to the current Federal Register notice, the July 23-24 advisory committee meeting will cover BPC-157, KPV, TB-500, MOTS-c, emideltide (DSIP), semax, and epitalon.

Other substances mentioned today by the HHS Secretary (e.g., GHK-Cu, Dihexa, ibutamoren, melanotan II, LL-37, thymosin beta-4 fragment) are currently not on that agenda and will presumably be taken up separately.

[FDAadcomms @FDAadcomms]

Link to meeting notice: https://t.co/MbEKezARUm

[FDAadcomms @FDAadcomms]

On July 23–24, 2026, an FDA advisory committee will evaluate whether multiple peptide substances—BPC-157, KPV, TB-500, MOTS-C, emideltide (DSIP), semax, and epitalon—should be added to the 503A compounding list, including review of proposed uses and sponsor presentations.

[FDAadcomms @FDAadcomms]

FR public inspection notice https://t.co/xsW2Z2fBII

[FDAadcomms @FDAadcomms]

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

[FDAadcomms @FDAadcomms]

This Thursday an FDA advisory committee will discuss Generative Artificial Intelligence-Enabled Digital Mental Health Medical Devices
Meeting materials: https://t.co/jxPWwHBhPl

[FDAadcomms @FDAadcomms]

Oct 9 #VRBPAC

[FDAadcomms @FDAadcomms]

Nov 6 adcomm
https://t.co/bjzNySuaSS

[FDAadcomms @FDAadcomms]

Vote 10-1 against

[FDAadcomms @FDAadcomms]

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)
https://t.co/YpFyh5W83Q

[FDAadcomms @FDAadcomms]

Vote 6-1 against

[FDAadcomms @FDAadcomms]

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

[FDAadcomms @FDAadcomms]

FDA has posted meeting materials for Thursday's adcomm for $GSK's belantamab mafodotin https://t.co/jezngeOz0G

[Adam Borecky, MD 🇺🇸 @DrAdamBorecky]

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. 🧵

[FDAadcomms @FDAadcomms]

Link: https://t.co/oer8BQm6d1

[FDAadcomms @FDAadcomms]

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.