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
$Arcutis Biotherapeutics(ARQT.US$ : 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
• 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
• 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
• 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
$Checkpoint Therapeutics(CKPT.US$ : CRL received 12/18
• Cosibelimab
⇒ PDUFA: 01/03/24
⇒ BLA
⇒ Cutaneous squamous cell carcinoma
$Ionis Pharmaceuticals(IONS.US$ :
• Eplontersen
⇒ PDUFA: 12/22/23
⇒ NDA
⇒ Transthyretin amyloidosis (ATTRv-PN)
• Eplontersen
⇒ PDUFA: 12/22/23
⇒ NDA
⇒ Transthyretin amyloidosis (ATTRv-PN)
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Joy Boy Myth : thank you Meltyy, I think you forgot to mention $Fortress Biotech (FBIO.US)$ $Fortress Biotech Inc Series A P (FBIOP.US)$
it's still has relation with $Checkpoint Therapeutics (CKPT.US)$
here the picture