🔔 FDA PDUFA Update…
See summary 👇
📣 4 PDUFAs upcoming in May:
$Dynavax Technologies(DVAX.US$ : 🤔
⇒ Heplisav-B
‣ vaccination of adults on hemodialysis
‣ PDUFA date: 5/13/24 (sBLA)
$Dynavax Technologies(DVAX.US$ : 🤔
⇒ Heplisav-B
‣ vaccination of adults on hemodialysis
‣ PDUFA date: 5/13/24 (sBLA)
$Bristol-Myers Squibb(BMY.US$ : 🤔
⇒ Breyanzi®
‣ PDUFA dates: (sBLAs)
‣‣ 5/23/24 (r/r follicular lymphoma)
‣‣ 5/31/24 (r/r mantle cell lymphoma)
⇒ Breyanzi®
‣ PDUFA dates: (sBLAs)
‣‣ 5/23/24 (r/r follicular lymphoma)
‣‣ 5/31/24 (r/r mantle cell lymphoma)
🗓️ Last week’s PDUFAs:
$X4 Pharmaceuticals(XFOR.US$ : Approved 4/29 🎉
⇨ XOLREMDI (mavorixafor)
‣ WHIM syndrome
‣ NDA
‣ PDUFA date: 4/30/24
$X4 Pharmaceuticals(XFOR.US$ : Approved 4/29 🎉
⇨ XOLREMDI (mavorixafor)
‣ WHIM syndrome
‣ NDA
‣ PDUFA date: 4/30/24
$Aquestive Therapeutics(AQST.US$ : Approved 4/29 🎉
⇨ Libervant™ (Diazepam) Buccal Film
‣ Seizure clusters (ages 2-5)
‣ NDA
‣ PDUFA date: 4/28/24
⇨ Libervant™ (Diazepam) Buccal Film
‣ Seizure clusters (ages 2-5)
‣ NDA
‣ PDUFA date: 4/28/24
$Neurocrine Biosciences(NBIX.US$ : Approved 4/30 🎉
⇨ INGREZZA
‣ tardive dyskinesia and Huntington's disease related chorea
‣ sNDA
‣ PDUFA date: 4/30/24
⇨ INGREZZA
‣ tardive dyskinesia and Huntington's disease related chorea
‣ sNDA
‣ PDUFA date: 4/30/24
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baqklin : thanks
74349332 : what site do you get this informatiom from?