Meltyy wrote a post · Mar 12, 2024 11:36

4 PDUFA decisions this week!

Last week’s PDUFAs:
$BeiGene (BGNE.US)$ : 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

$Vanda Pharmaceuticals (VNDA.US)$ : CRL 3/4 🙁
⇒ HETLIOZ®
⇒ insomnia
⇒ sNDA
⇒ PDUFA: 03/04/24

$Eyenovia (EYEN.US)$ : Approved 3/4 🎉
⇒ 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

📌 This week’s PDUFAs 🚨
$Mirum Pharmaceuticals (MIRM.US)$ : 🤔
⇒ 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

$Madrigal Pharmaceuticals (MDGL.US)$ : 🤔
⇒ Resmetirom
⇒ NASH/MASH
⇒ NDA
⇒ PDUFA: 3/14/24

$OptiNose (OPTN.US)$ : 🤔
⇒ XHANCE (fluticasone propionate)
⇒ chronic sinusitis
⇒ sNDA
⇒ PDUFA: 3/16/24

Disclaimer: Community is offered by Moomoo Technologies Inc. and is for educational purposes only. Read more

Translate

Report

297K Views

Comment

SpyderCall : Very valuable info as usual. Thanks for the hard work.

Report
Reply

Cancel Reply
shintaka1168 : It was amazing that they distributed this kind of information. I think I'll check it out again

Report
Reply

Cancel Reply

Meltyy

挣钱养猫猫😺

2239

Followers

Following

19K

Visitors