4 PDUFAs in January 2025! 🎆🚀
Bristol Myers Squibb recently received approval for Opdivo Qvantig™, the first and only SC administered PD-1 inhibitor. Additionally, BeiGene secured approval for Tislelizumab + chemotherapy to treat gastric or gastroesophageal junction adenocarcinoma. Mirum Pharmaceuticals, however, is yet to announce the outcome of their NDA for Chenodal® (chenodiol).
See summary for more details on recent FDA decisions & upcoming PDUFA events.👇
🗓️ Last Week’s PDUFAs:
MIRM : pending decision 🤔
⇨ Chenodal® (chenodiol)
‣ Cerebrotendinous xanthomatosis
‣ PDUFA: 12/28/24 (NDA)
BMY: Approved 12/27/24 ✅
⇨ Opdivo Qvantig (nivolumab + hyaluronidase) SC injection
‣ previously approved adult, solid tumor Opdivo® indications
‣ PDUFA: 12/29/24 (BLA)
BGNE: Approved 12/27/24 ✅
⇨ Tislelizumab + chemo
‣ Gastric or gastroesophageal junction (G/GEJ) adenocarcinoma
‣ PDUFA: December 2024 (BLA)
❄️ Upcoming PDUFAs in Jan ‘25
ATRA: Tab-cel (tabelecleucel)
BIIB: Leqembi (Lecanemab) IV Maintenance Dosing
VRTX: Suzetrigine (VX-548)
AXSM: AXS-07 (MoSEIC COX-2 pref inhibitor)
Check out also the December & January PDUFA calendars below. 📸 👇
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Article history:
First published 12/31/24 AV, DG & EJV