🚨 FDA PDUFA Update…
1 PDUFA this week! 🔥
$Arcutis Biotherapeutics (ARQT.US)$ : pending decision 🤔
⇨ ARQ-151 topical roflumilast cream
‣ Atopic Dermatitis (aged 6 & older children)
‣ PDUFA date: 7/7/24 (sNDA)
⇨ ARQ-151 topical roflumilast cream
‣ Atopic Dermatitis (aged 6 & older children)
‣ PDUFA date: 7/7/24 (sNDA)
Upcoming PDUFAs & AdCom in July: 📅👇
$Phathom Pharmaceuticals (PHAT.US)$ : 🤔
⇨ VOQUEZNA® (vonoprazan)
‣ Non-Erosive GERD
‣ PDUFA date: 7/19/24 (NDA)
⇨ VOQUEZNA® (vonoprazan)
‣ Non-Erosive GERD
‣ PDUFA date: 7/19/24 (NDA)
$AstraZeneca (AZN.US)$ : AdCom 🤔
⇨ Imfinzi + chemotherapy
‣ Neoadjuvant treatment NSCLC
‣ AdCom date: 7/25/24(sBLA)
⇨ Imfinzi + chemotherapy
‣ Neoadjuvant treatment NSCLC
‣ AdCom date: 7/25/24(sBLA)
$BeiGene (BGNE.US)$ : 🤔
⇨ TEVIMBRA (tislelizumab)
‣ Esophageal squamous-cell carcinomas
‣ PDUFA date: July 2024 (BLA)
⇨ TEVIMBRA (tislelizumab)
‣ Esophageal squamous-cell carcinomas
‣ PDUFA date: July 2024 (BLA)
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