4 PDUFA decisions this week!
Last week’s PDUFAs:
$BeiGene(BGNE.US$ : Approved 3/8 🎉
⇒ BRUKINSA + obinutuzumab
⇒ Follicular Lymphoma
⇒ sNDA
⇒ PDUFA date: Mar 2024
$BeiGene(BGNE.US$ : Approved 3/8 🎉
⇒ BRUKINSA + obinutuzumab
⇒ Follicular Lymphoma
⇒ sNDA
⇒ PDUFA date: Mar 2024
$Bristol-Myers Squibb(BMY.US$ : Approved 3/8 🎉
⇒ Opdivo ® + Cisplatin & Gemcitabine
⇒ Urothelial carcinoma
⇒ sBLA
⇒ PDUFA: 04/05/24
⇒ Opdivo ® + Cisplatin & Gemcitabine
⇒ Urothelial carcinoma
⇒ sBLA
⇒ PDUFA: 04/05/24
$Eyenovia(EYEN.US$ : Approved 3/4 🎉
⇒ Clobetasol propionate ophthalmic susp. 0.05% (APP13007)
⇒ postop eye pain and inflammation
⇒ NDA
⇒ PDUFA: 03/04/24
⇒ Clobetasol propionate ophthalmic susp. 0.05% (APP13007)
⇒ postop eye pain and inflammation
⇒ NDA
⇒ PDUFA: 03/04/24
$Lantheus(LNTH.US$ : Approved 3/4 🎉
⇒ DEFINITY (Perflutren Lipid Microsphere)
⇒ ultrasound enhancing agent for pedia use
⇒ sNDA
⇒ DEFINITY (Perflutren Lipid Microsphere)
⇒ ultrasound enhancing agent for pedia use
⇒ sNDA
📌 This week’s PDUFAs 🚨
$Mirum Pharmaceuticals(MIRM.US$ : 🤔
⇒ LIVMARLI (Maralixibat)
⇒ progressive familial intrahepatic cholestasis (PFIC)
⇒ sNDA
⇒ PDUFA: 03/13/24
$Mirum Pharmaceuticals(MIRM.US$ : 🤔
⇒ LIVMARLI (Maralixibat)
⇒ progressive familial intrahepatic cholestasis (PFIC)
⇒ sNDA
⇒ PDUFA: 03/13/24
$Bristol-Myers Squibb(BMY.US$ : 🤔
⇒ Breyanzi® (lisocabtagene maraleucel)
⇒ CLL or SLL
⇒ sBLA
⇒ PDUFA: 3/14/24
⇒ Breyanzi® (lisocabtagene maraleucel)
⇒ CLL or SLL
⇒ sBLA
⇒ PDUFA: 3/14/24
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SpyderCall : Very valuable info as usual. Thanks for the hard work.
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shintaka1168 : It was amazing that they distributed this kind of information. I think I'll check it out again