🔔 FDA PDUFA Update…

🔥 3 PDUFA decisions this week! 👇

📌 This week’s PDUFAs:
$Merck & Co (MRK.US)$ : 🤔
⇨ Patritumab deruxtecan
‣ Non-small cell lung carcinoma
‣ PDUFA date: 6/26/24 (BLA)

$Verona Pharma (VRNA.US)$ : 🤔
⇨ Ensifentrine (Nebulized)
‣ Chronic obstructive pulmonary disease
‣ PDUFA date: 6/26/24 (NDA)

$Genmab (GMAB.US)$ : 🤔
⇨ EPKINLY® (Epcoritamab)
‣ Follicular lymphoma
‣ PDUFA date: 6/28/24 (sBLA)

🗓️ Last week’s PDUFAs:
$Merck & Co (MRK.US)$ : Approved 6/17 🎉
⇨ CAPVAXIVE (V116)
‣ Pneumococcal conjugate vaccine
‣ PDUFA date: 6/17/24 (BLA)

$Harmony Biosciences (HRMY.US)$ : Approved 6/21 🎉
⇨ WAKIX® (pitolisant)
‣ Narcolepsy (Pediatric)
‣ PDUFA date: 6/21/24 (sNDA)

$Merck & Co (MRK.US)$ : Approved 6/17 🎉
⇨ KEYTRUDA +carboplatin + paclitaxel
‣ Endometrial carcinoma
‣ PDUFA date: 6/21/24 (sBLA)

$argenx SE (ARGX.US)$ : Approved 6/21 🎉
⇨ VYVGART Hytrulo (Efgartigimod)
‣ Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
‣ PDUFA date: 6/21/24 (sBLA)

$Sarepta Therapeutics (SRPT.US)$ : Approved 6/20 🎉
⇨ ELEVIDYS (SRP-9001)
‣ Duchenne muscular dystrophy
‣ PDUFA date: 6/21/24 (sBLA)

$Bristol-Myers Squibb (BMY.US)$ : Approved 6/21 🎉
⇨ KRAZATI (Adagrasib) + Cetuximab
‣ Colorectal cancer
‣ PDUFA date: 6/21/24 (sNDA)