$Liquidia(LQDA.US)$PDUFA;FDA update📢 ⇒ NDA review remains ongoing ⇒ Confirms the process for adding the PH-ILD indication as an amendment ⇒ Couldn't issue an action letter in time 📍• YUTREPIA ⇒ PDUFA goal date: 1/24/24 ⇒ NDA ⇒ PH-ILD
$Liquidia(LQDA.US)$The FDA Informed Liquidia That It Is Adding Pulmonary Hypertension Associated With Interstitial Lung Disease Indication As An Amendment To Yutrepia Application, Hence It Will Not Be Able To Meet The Prescription Drug User Fee Act Goal Date Of January 24. , and their review remains ongoing. The FDA did not request any additional clinical data to support the NDA and did not issue a new PDUFA goal date. Moomoo 24/7· 2 mins ago
Trytosaveabit楼主JESSE JAMES8832:
Good morning! Yeah you and me both! Amazing isnt how the FDA can just like that extend the time needed just because the company wants to add another treatment to which the medication can treat? GL today
TrytosaveabitJESSE JAMES8832楼主:
Thanks brother, guess you see $Heron Therapeutics (HRTX.US)$ , so far the PM isn’t impressed with the approval to update the label to use for the treatment of other ailments? I mean i didn’t expect a 100% move. But I figured it would get a good bounce? Maybe into MO it will get some attention?
Liquidia股票讨论区
🗓️ Last week’s PDUFAs:
$辉瑞(PFE.US)$ : Approved 4/26 🎉
⇨ BEQVEZ (fidanacogene elaparvovec-dzkt)
▹ Hemophilia B
▹ BLA
▹ PDUFA date: Q2 2024
$Day One Biopharmaceuticals(DAWN.US)$ : Approved 4/23 🎉
⇨ OJEMDA (tovorafenib)
▹ Pediatric low-grade glioma
▹ NDA
▹ PDUFA date: 4/30/24
$ImmunityBio(IBRX.US)$ : Approved 4/22 🎉
⇨ Anktiva + BCG
▹ Bladder cancer
▹ resubmitted BLA
▹ PDUFA date: 4/23/24
$Abeona Therapeutics(ABEO.US)$ : CRL 4/22 🙁
⚠...
$Supernus Pharmaceuticals(SUPN.US)$ : CRL 4/8/24 🙁
⇒ SPN-830
⇒ OFF episodes in PD
⇒ NDA
⇒ PDUFA: 4/5/24
$传奇生物(LEGN.US)$ & $强生(JNJ.US)$ : Approved 🎉
⇒ CARVYKTI (cilta-cel)
⇒ Multiple myeloma
⇒ sBLA
⇒ PDUFA: 4/5/24
$阿斯利康(AZN.US)$ : Approved 🎉
⇒ Enhertu
⇒ HER2+ solid tumors
⇒ sBLA
⇒ PDUFA: Q2 2024
$2seventy bio(TSVT.US)$ & $施贵宝(BMY.US)$ : Approved 🎉
⇒ Abecma
⇒ Multiple myeloma
⇒ sBLA
⇒ Delayed PDUFA
$万达生物制药(VNDA.US)$...
$万达生物制药(VNDA.US)$ $传奇生物(LEGN.US)$ $Supernus Pharmaceuticals(SUPN.US)$ $ImmunityBio(IBRX.US)$ $Aquestive Therapeutics(AQST.US)$ $X4制药(XFOR.US)$ $Liquidia(LQDA.US)$ $神经分泌生物科学(NBIX.US)$ $Moderna(MRNA.US)$ $Day One Biopharmaceuticals(DAWN.US)$
...
$Eyenovia(EYEN.US)$ $万达生物制药(VNDA.US)$ $Mirum Pharmaceuticals(MIRM.US)$ $Madrigal Pharmaceuticals(MDGL.US)$ $杰龙(GERN.US)$ $施贵宝(BMY.US)$ $2seventy bio(TSVT.US)$ $传奇生物(LEGN.US)$ $OptiNose(OPTN.US)$ $Orchard Therapeutics(ORTX.US)$ $默沙东(MRK.US)$ $Akebia Therapeutics(AKBA.US)$ $阿斯利康(AZN.US)$ $Liquidia(LQDA.US)$ $Esperion Therapeutics(ESPR.US)$ $再生元制药公司(REGN.US)$ $百济神州(BGNE.US)$
$Heron Therapeutics(HRTX.US)$ : Approved 1/23 🎉
⇒ ZYNRELEF
⇒ Postoperative pain
⇒ sNDA
⇒ PDUFA: 01/23/24
$Liquidia(LQDA.US)$ : NDA review ongoing 🤔
⇒ YUTREPIA
⇒ PH-ILD
⇒ NDA
⇒ PDUFA: 01/24/24
$Theratechnologies(THTX.US)$ : CRL 1/24 🙁
⇒ F8 Formulation of Tesamorelin
⇒ Excess abdominal fat in adults w/ HIV
⇒ sBLA
⇒ PDUFA: 01/22/24
$赛诺菲安万特(SNY.US)$ & $再生元制药公司(REGN.US)$ : Approved 1/25 🎉
⇒ Dupixent
⇒ Eosinophilic esophagitis (pedia)
⇒ sB...
⇒ NDA review remains ongoing
⇒ Confirms the process for adding the PH-ILD
indication as an amendment
⇒ Couldn't issue an action letter in time
📍• YUTREPIA
⇒ PDUFA goal date: 1/24/24
⇒ NDA
⇒ PH-ILD
Moomoo 24/7· 2 mins ago
$Heron Therapeutics(HRTX.US)$ : 🤔
⇒ ZYNRELEF
⇒ Postoperative pain
⇒ sNDA
⇒ PDUFA: 01/23/24
$Liquidia(LQDA.US)$ : 🤔
⇒ YUTREPIA
⇒ PH-ILD
⇒ NDA
⇒ PDUFA: 01/24/24
📌Next week’s PDUFAs:
$赛诺菲安万特(SNY.US)$ & $再生元制药公司(REGN.US)$ : 🤔
⇒ Dupixent
⇒ Eosinophilic Esophagitis (pedia)
⇒ sBLA
⇒ PDUFA: 01/31/24
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