$Liquidia(LQDA.US)$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
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