🚨 1 PDUFA this week!

See FDA PDUFA update 👇

$Applied Therapeutics (APLT.US)$ : 🤔
⇨ Govorestat
‣ Classic Galactosemia
‣ PDUFA: 11/28/24 (NDA)

🗓️ Last Week’s Adcom & PDUFA decisions:
$BridgeBio Pharma (BBIO.US)$ : Approved 11/22 ✅
⇨Attruby (Acoramidis)
‣ ATTR-CM (transthyretin amyloid cardiomyopathy)
‣ PDUFA: 11/29/24 (NDA)

$AstraZeneca (AZN.US)$ : Discussion, no vote
⇨ Andexxa (coagulation factor Xa)
‣ Life-threatening or uncontrolled bleeding
‣ Adcom: 11/21/24 (sBLA)

$Jazz Pharmaceuticals (JAZZ.US)$ & $Zymeworks (ZYME.US)$ : Approved 11/20 ✅
⇨ Ziihera (zanidatamab)
‣ HER2-positive biliary tract cancer
‣ PDUFA: 12/29/24 (BLA)