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Meltyy wrote a post · Apr 30 04:09

🔔 FDA PDUFA Update…

📣 3 PDUFAs left in April! See summary 👇

🗓️ Last week’s PDUFAs:
$Pfizer(PFE.US)$ : Approved 4/26 🎉
⇨ BEQVEZ (fidanacogene elaparvovec-dzkt)
▹ Hemophilia B
▹ BLA
▹ PDUFA date: Q2 2024

$Day One Biopharmaceuticals(DAWN.US)$ : Approved 4/23 🎉
⇨ OJEMDA (tovorafenib)
▹ Pediatric low-grade glioma
▹ NDA
▹ PDUFA date: 4/30/24

$ImmunityBio(IBRX.US)$ : Approved 4/22 🎉
⇨ Anktiva + BCG
▹ Bladder cancer
▹ resubmitted BLA
▹ PDUFA date: 4/23/24

$Abeona Therapeutics(ABEO.US)$ : CRL 4/22 🙁
⚠ needs add'l CMC info
⇨ Prademagene zamikeracel (pz-cel)
▹ recessive dystrophic epidermolysis bullosa
▹ BLA
▹ PDUFA date: 5/25/24

🚨 This week’s PDUFAs:
$X4 Pharmaceuticals(XFOR.US)$ : 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

$Neurocrine Biosciences(NBIX.US)$ : 🤔
⇨ INGREZZA
▹ tardive dyskinesia and Huntington's disease related chorea
▹ sNDA
▹ PDUFA date: 4/30/24

$Moderna(MRNA.US)$ : 🤔
⇨ mRNA-1345
▹ Respiratory syncytial virus
▹ BLA
▹ PDUFA date: April 2024 (est.)

$Liquidia(LQDA.US)$ : 🤔
⇨ YUTREPIA
▹ pulmonary hypertension associated w/ interstitial lung disease
▹ NDA
▹ PDUFA date: April 2024 (est.)
🔔 FDA PDUFA Update…
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Meltyy
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