📅 FDA PDUFA Update…

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

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

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

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

📌 PDUFAs in the Next Few Weeks: 👀
$Citius Pharmaceuticals (CTXR.US)$ LYMPHIR
$Gilead Sciences (GILD.US)$ Seladelpar
$Ascendis Pharma A/S (ASND.US)$ YORVIPATH®
$Agios Pharmaceuticals (AGIO.US)$ Vorasidenib
$Regeneron Pharmaceuticals (REGN.US)$ Linvoseltamab
$Syndax Pharmaceuticals (SNDX.US)$ & $Incyte (INCY.US)$ Axatilimab
$scPharmaceuticals (SCPH.US)$ FUROSCIX