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PDUFA Update…

Last week’s PDUFAs:
$Arcutis Biotherapeutics(ARQT.US)$ : Approved 12/15
• ZORYVE® (Roflumilast foam 0.3%)
⇒ topical foam
⇒ PDUFA: 12/16/23
⇒ NDA
⇒ Seborrheic dermatitis

$Merck & Co(MRK.US)$ : Approved 12/15
• KEYTRUDA (pembrolizumab) + Padcev (enfortumab vedotin-ejfv)
⇒ IV injection
⇒ PDUFA: 05/09/24
⇒ sBLA
⇒ Urothelial cancer

$Glaukos(GKOS.US)$ : Approved 12/14
• iDose® TR (travoprost)
⇒ intracameral implant
⇒ PDUFA: 12/22/23
⇒ NDA
⇒ Glaucoma

$Merck & Co(MRK.US)$ : Approved 12/14
• WELIREG® (belzutifan)
⇒ oral tablets
⇒ PDUFA: 01/17/24
⇒ sNDA
⇒ Advanced Renal Cell Carcinoma

This week’s PDUFAs:
$Checkpoint Therapeutics(CKPT.US)$ : CRL received 12/18
• Cosibelimab
⇒ PDUFA: 01/03/24
⇒ BLA
⇒ Cutaneous squamous cell carcinoma

$Calliditas Therapeutics(CALT.US)$ :
• TARPEYO (Nafecon)
⇒ PDUFA: 12/20/23
⇒ sNDA
⇒ IgA nephropathy

$Ionis Pharmaceuticals(IONS.US)$ :
• Eplontersen
⇒ PDUFA: 12/22/23
⇒ NDA
⇒ Transthyretin amyloidosis (ATTRv-PN)
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