PDUFA Update…
4 FDA approvals last week
1 PDUFA event left in Feb 2024
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
$AstraZeneca(AZN.US$ : 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
⇒ 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
⇒ 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
⇒ 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
$Minerva Neurosciences(NERV.US$ :
⇒ Roluperidone
⇒ Negative symptoms of schizophrenia
⇒ NDA
⇒ PDUFA: 02/26/24
Disclaimer: Community is offered by Moomoo Technologies Inc. and is for educational purposes only.
Read more
Comment
Sign in to post a comment
102877280 : so many good news should elevate the stock price, but...