📅 FDA PDUFA & AdCom Update…

📣 ITRM AdCom 9/9 meeting ongoing 🚗
👀 stay tuned for updates on meeting outcomes
See 👇 for further info.

🚨 This Week’s AdCom:
$Iterum Therapeutics (ITRM.US)$ : Meeting ongoing 🤔
⇨ Sulopenem
‣ uUTI (Uncomplicated Urinary Tract Infection)
‣ AdCom: 9/9/24

🚨 Last Week’s PDUFAs:
$Travere Therapeutic (TVTX.US)$ : Approved 9/5 🎉
⇨ FILSPARI (Sparsentan)
‣ IgA nephropathy (IgAN)
‣ PDUFA: 9/5/24

$Avadel Pharmaceuticals (AVDL.US)$ : Awaiting decision 🤔
⇨ LUMRYZ (sodium oxybate)
‣ pediatric narcolepsy
‣ PDUFA: 9/7/24

📌 PDUFAs & AdComs in Upcoming Weeks 👀:
$Sanofi (SNY.US)$ & $Regeneron Pharmaceuticals (REGN.US)$ : Dupixent
$Vanda Pharmaceuticals (VNDA.US)$ : Tradipitant
$Zevra Therapeutics (ZVRA.US)$ : Arimoclomol
$Heron Therapeutics (HRTX.US)$ : ZYNRELEF® Vial Access Needle
$Merck & Co (MRK.US)$ : KEYTRUDA+ chemotherapy
$Bristol-Myers Squibb (BMY.US)$ : KarXT (xanomeline-trospium)
$Merck & Co (MRK.US)$ $BeiGene (BGNE.US)$ $Bristol-Myers Squibb (BMY.US)$ : KEYTRUDA, Tislelizumab, YERVOY & OPDIVO - AdCom 🗓️
$Sanofi (SNY.US)$ & $Regeneron Pharmaceuticals (REGN.US)$ : Dupixent
$Sanofi (SNY.US)$ : Sarclisa®
$ROCHE HOLDING AG (RHHBY.US)$ : OCREVUS (ocrelizumab) w/ ENHANZE