See FDA PDUFA update 👀 👇
🚨 This Week’s PDUFAs:
$Heron Therapeutics (HRTX.US)$ : 🤔
⇨ ZYNRELEF® Vial Access Needle
‣ Postoperative pain
‣ PDUFA: 9/23/24 (sNDA)
$Heron Therapeutics (HRTX.US)$ : 🤔
⇨ ZYNRELEF® Vial Access Needle
‣ Postoperative pain
‣ PDUFA: 9/23/24 (sNDA)
$Bristol-Myers Squibb (BMY.US)$ : 🤔
⇨ KarXT (xanomeline-trospium)
‣ Schizophrenia
‣ PDUFA: 9/26/24 (NDA)
⇨ KarXT (xanomeline-trospium)
‣ Schizophrenia
‣ PDUFA: 9/26/24 (NDA)
$Sanofi (SNY.US)$ $Regeneron Pharmaceuticals (REGN.US)$ : 🤔
⇨ Dupixent
‣ Chronic obstructive pulmonary disease
‣ PDUFA: 9/27/24 (sBLA)
⇨ Dupixent
‣ Chronic obstructive pulmonary disease
‣ PDUFA: 9/27/24 (sBLA)
$BeiGene (BGNE.US)$ $Merck & Co (MRK.US)$ & $Bristol-Myers Squibb (BMY.US)$ : 🤔
⇨ Tislelizumab, KEYTRUDA, OPDIVO & YERVOY
‣ Gastric and gastroesophageal junction adenocarcinoma
‣ Adcom: 9/26/24
⇨ Tislelizumab, KEYTRUDA, OPDIVO & YERVOY
‣ Gastric and gastroesophageal junction adenocarcinoma
‣ Adcom: 9/26/24
📣 Last Week’s PDUFAs:
$Vanda Pharmaceuticals (VNDA.US)$ : CRL ❌
⇨ Tradipitant
‣ Gastroparesis
‣ PDUFA: 9/18/24 (NDA)
$Vanda Pharmaceuticals (VNDA.US)$ : CRL ❌
⇨ Tradipitant
‣ Gastroparesis
‣ PDUFA: 9/18/24 (NDA)
$Zevra Therapeutics (ZVRA.US)$ : Approved ✅
⇨ MIPLYFFA™ (arimoclomol)
‣ Niemann-Pick disease Type C
‣ PDUFA: 9/21/24 (NDA)
⇨ MIPLYFFA™ (arimoclomol)
‣ Niemann-Pick disease Type C
‣ PDUFA: 9/21/24 (NDA)
$Merck & Co (MRK.US)$ : Approved ✅
⇨ KEYTRUDA + chemotherapy
‣ 1L Pleural Mesothelioma
‣ PDUFA: 9/25/24 (sBLA)
⇨ KEYTRUDA + chemotherapy
‣ 1L Pleural Mesothelioma
‣ PDUFA: 9/25/24 (sBLA)
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