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FDA PDUFA Update…

🗓️ Last week’s PDUFAs:
$Akebia Therapeutics (AKBA.US)$ : Approved 🎉
⇒ Vafseo (Vadadustat)
⇒ Anemia due to CKD
⇒ NDA
⇒ PDUFA: 3/27/24

$Merck & Co (MRK.US)$ : Approved 🎉
⇒ WINREVAIR (sotatercept)
⇒ Pulmonary arterial hypertension
⇒ BLA
⇒ PDUFA: 3/26/24

$AstraZeneca (AZN.US)$ : Approved 🎉
⇒ Ultomiris (ravulizumab)
⇒ NMOSD
⇒ sBLA

$Regeneron Pharmaceuticals (REGN.US)$ : CRL 🙁
⇒ Odronextamab
⇒ r/r FL and r/r DLBCL
⇒ BLA
⇒ PDUFA: 3/31/24

📌 This week’s PDUFAs: 🚨
$AstraZeneca (AZN.US)$ : 🤔
⇒ FluMist (self-admin)
⇒ Influenza
⇒ sBLA
⇒ Q1 2024

$Vanda Pharmaceuticals (VNDA.US)$ : 🤔
⇒ Fanapt® (iloperidone)
⇒ Bipolar I disorder
⇒ sNDA
⇒ PDUFA: 4/2/24

$Supernus Pharmaceuticals (SUPN.US)$ : 🤔
⇒ Apomorphine infusion device (SPN-830)
⇒ OFF episodes in PD
⇒ NDA
⇒ PDUFA: 4/5/24

$Legend Biotech (LEGN.US)$ : 🤔
⇒ CARVYKTI (cilta-cel)
⇒ Multiple myeloma
⇒ sBLA
⇒ PDUFA: 4/5/24

$IMGN
⇒ ELAHERE (Mirvetuximab soravtansine)
⇒ Ovarian cancer
⇒ sBLA
⇒ PDUFA: 4/5/24
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