Meltyy wrote a post · Jun 11 16:48

🔔 FDA PDUFA Update…

🚨 1 AdCom & 3 PDUFA decisions this week:

$Genfit (GNFT.US)$ & $IPSEN SA SPONS ADR EA REPR 0.25 ORD (IPSEY.US)$ : 🤔
⇨ Elafibranor
‣ Primary biliary cholangitis
‣ PDUFA date: 6/10/24

$Regeneron Pharmaceuticals (REGN.US)$ : 🤔
⇨ Kevzara (sarilumab)
‣ Polyarticular juvenile idiopathic arthritis
‣ PDUFA date: 6/10/24

$Bristol-Myers Squibb (BMY.US)$ : 🤔
⇨ Augtyro™ (Repotrectinib)
‣ PDUFA date: 6/15/24 (sNDA)

🗓️ Last week’s PDUFAs:
$GlaxoSmithKline (GSK.US)$ : Approved 6/7 🎉
⇨ Arexvy
‣ Respiratory syncytial virus
‣ PDUFA date: 6/7/24 (sBLA)

$Geron (GERN.US)$ : Approved 6/6 🎉
⇨ RYTELO™ (imetelstat)
‣ lower-risk MDS w/ transfusion-dependent anemia 🩸
‣ PDUFA date: 6/16/24 (NDA)

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