FDA PDUFA Update…
🗓️ Last week’s PDUFAs:
$Akebia Therapeutics(AKBA.US$ : Approved 🎉
⇒ Vafseo (Vadadustat)
⇒ Anemia due to CKD
⇒ NDA
⇒ PDUFA: 3/27/24
$Akebia Therapeutics(AKBA.US$ : 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
⇒ WINREVAIR (sotatercept)
⇒ Pulmonary arterial hypertension
⇒ BLA
⇒ PDUFA: 3/26/24
$Regeneron Pharmaceuticals(REGN.US$ : CRL 🙁
⇒ Odronextamab
⇒ r/r FL and r/r DLBCL
⇒ BLA
⇒ PDUFA: 3/31/24
⇒ Odronextamab
⇒ r/r FL and r/r DLBCL
⇒ BLA
⇒ PDUFA: 3/31/24
$Supernus Pharmaceuticals(SUPN.US$ : 🤔
⇒ Apomorphine infusion device (SPN-830)
⇒ OFF episodes in PD
⇒ NDA
⇒ PDUFA: 4/5/24
⇒ Apomorphine infusion device (SPN-830)
⇒ OFF episodes in PD
⇒ NDA
⇒ PDUFA: 4/5/24
$IMGN
⇒ ELAHERE (Mirvetuximab soravtansine)
⇒ Ovarian cancer
⇒ sBLA
⇒ PDUFA: 4/5/24
⇒ ELAHERE (Mirvetuximab soravtansine)
⇒ Ovarian cancer
⇒ sBLA
⇒ PDUFA: 4/5/24
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Strike freedom : Don’t have akebia?
MeltyyOP Strike freedom: the first of the post
Strike freedom MeltyyOP: I mean in the April calendar
Srav Reddy : Wonder why $Akebia Therapeutics (AKBA.US)$ dropped after PDUFA