📅 FDA PDUFA Update…

🚨 This Week’s PDUFA:
$HUMA.US$ : 🤔
⇨ Human Acellular Vessel (HAV)™
‣ Vascular Trauma
‣ PDUFA: 8/10/24 (BLA)

🗓️ Last Week’s AdCom & PDUFAs:
$ZVRA.US$ : Favorable AdCom 👍
🗳️ 11-5 votes in favor
⇨ Arimoclomol
‣ Niemann-Pick disease type C
‣ AdCom: 8/2/24 (NDA)

$ADAP.US$ : Approved 🎉
⇨ TECELRA (afamitresgene autoleucel)
‣ Synovial sarcoma
‣ PDUFA: 8/4/24 (BLA)

$GSK.US$ : Approved 🎉
⇨ Jemperli
‣ Endometrial cancer
‣ PDUFA: 8/23/24 (sBLA)

📌 PDUFAs in the Next Few Weeks: 👀
$CTXR.US$ LYMPHIR
$GILD.US$ Seladelpar
$ASND.US$ YORVIPATH®
$AGIO.US$ Vorasidenib
$REGN.US$ Linvoseltamab
$SNDX.US$ & $INCY.US$ Axatilimab
$SCPH.US$ FUROSCIX