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PDUFA Update…

4 FDA approvals last week
1 PDUFA event left in Feb 2024

Last week’s PDUFAs:
$AstraZeneca(AZN.US)$ : Approved 2/16
⇒ Tagrisso (osimertinib) + chemotherapy
⇒ NSCLC
⇒ sNDA
⇒ PDUFA: Q1 2024

$Iovance Biotherapeutics(IOVA.US)$ : Approved 2/16
⇒ AMTAGVI™ (lifileucel)
⇒ Melanoma
⇒ BLA
⇒ PDUFA: 02/24/24

$ROCHE HOLDING AG(RHHBY.US)$ : Approved 2/16
⇒ Xolair® (omalizumab)
⇒ IgE-mediated food allergy
⇒ sBLA
⇒ PDUFA: Q1 2024

$IPSEY & $Merrimack Pharmaceuticals(MACK.US)$ : Approved 2/13
⇒ Onivyde (irinotecan liposome injection) + 5 fluorouracil/leucovorin & oxaliplatin
⇒ mPDAC
⇒ sNDA
⇒ PDUFA: 02/13/24

1 PDUFA event left in Feb
$Minerva Neurosciences(NERV.US)$ :
⇒ Roluperidone
⇒ Negative symptoms of schizophrenia
⇒ NDA
⇒ PDUFA: 02/26/24
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