PDUFA Update…
📌Last week’s PDUFAs:
$Heron Therapeutics(HRTX.US$ : Approved 1/23 🎉
⇒ ZYNRELEF
⇒ Postoperative pain
⇒ sNDA
⇒ PDUFA: 01/23/24
$Heron Therapeutics(HRTX.US$ : Approved 1/23 🎉
⇒ ZYNRELEF
⇒ Postoperative pain
⇒ sNDA
⇒ PDUFA: 01/23/24
$Theratechnologies(THTX.US$ : CRL 1/24 🙁
⇒ F8 Formulation of Tesamorelin
⇒ Excess abdominal fat in adults w/ HIV
⇒ sBLA
⇒ PDUFA: 01/22/24
⇒ F8 Formulation of Tesamorelin
⇒ Excess abdominal fat in adults w/ HIV
⇒ sBLA
⇒ PDUFA: 01/22/24
$Sanofi(SNY.US$ & $Regeneron Pharmaceuticals(REGN.US$ : Approved 1/25 🎉
⇒ Dupixent
⇒ Eosinophilic esophagitis (pedia)
⇒ sBLA
⇒ PDUFA: 01/31/24
⇒ Dupixent
⇒ Eosinophilic esophagitis (pedia)
⇒ sBLA
⇒ PDUFA: 01/31/24
🚨 Upcoming PDUFAs in Feb: 🚨
$IPSEY & $Merrimack Pharmaceuticals(MACK.US$ : 🤔
⇒ Onivyde + 5 fluorouracil/leucovorin & oxaliplatin
⇒ Pancreatic cancer
⇒ sNDA
⇒ PDUFA: 02/13/24
$IPSEY & $Merrimack Pharmaceuticals(MACK.US$ : 🤔
⇒ Onivyde + 5 fluorouracil/leucovorin & oxaliplatin
⇒ Pancreatic cancer
⇒ sNDA
⇒ PDUFA: 02/13/24
$Minerva Neurosciences(NERV.US$ : 🤔
⇒ Roluperidone
⇒ Negative symptoms of schizophrenia
⇒ NDA
⇒ PDUFA: 02/26/24
⇒ Roluperidone
⇒ Negative symptoms of schizophrenia
⇒ NDA
⇒ PDUFA: 02/26/24
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TennesseeRob : So close to Heroin its almost avoidable