🔔 FDA PDUFA Update…
📣 2 PDUFAs left in May!
🗓️ Last week’s PDUFAs:
$Amgen (AMGN.US)$ : Approved 5/16 🎉
⇒ Imdelltra (Tarlatamab-dlle)
‣ extensive-stage SCLC
‣ PDUFA date: 6/12/24 (BLA)
⇒ Imdelltra (Tarlatamab-dlle)
‣ extensive-stage SCLC
‣ PDUFA date: 6/12/24 (BLA)
$Bristol-Myers Squibb (BMY.US)$ : Approved 5/15 🎉
⇒ Breyanzi®
‣ Follicular lymphoma
‣ PDUFA date: 5/23/24 (sBLAs)
⇒ Breyanzi®
‣ Follicular lymphoma
‣ PDUFA date: 5/23/24 (sBLAs)
$Dynavax Technologies (DVAX.US)$ : CRL 5/14 🙁
⚠️ insufficient data
⇒ Heplisav-B
‣ vaccination of adults on hemodialysis
‣ PDUFA date: 5/13/24 (sBLA)
⚠️ insufficient data
⇒ Heplisav-B
‣ vaccination of adults on hemodialysis
‣ PDUFA date: 5/13/24 (sBLA)
$Ascendis Pharma A/S (ASND.US)$ : Review extended to 8/14/24 🤔
⇒ YORVIPATH®
‣ hypoparathyroidism
‣ Initial PDUFA date: 5/14/24 (NDA)
⇒ YORVIPATH®
‣ hypoparathyroidism
‣ Initial PDUFA date: 5/14/24 (NDA)
📌 Remaining PDUFAs this month:
$Bristol-Myers Squibb (BMY.US)$ : 🤔
⇒ Breyanzi
‣ r/r mantle cell lymphoma
‣ PDUFA date: 5/31/24 (sBLA)
$Bristol-Myers Squibb (BMY.US)$ : 🤔
⇒ Breyanzi
‣ r/r mantle cell lymphoma
‣ PDUFA date: 5/31/24 (sBLA)
$Moderna (MRNA.US)$ : 🤔
⇒ mRNA-1345
‣ Respiratory syncytial virus
‣ PDUFA date: End of May 2024 (est.) (BLA)
⇒ mRNA-1345
‣ Respiratory syncytial virus
‣ PDUFA date: End of May 2024 (est.) (BLA)
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