Regulatory Updates
Sep 18, 2026•1 min read
FDA Grants Priority Approval for AstraZeneca's IMFINZI (Durvalumab) BLA761069
The FDA approved AstraZeneca’s IMFINZI (durvalumab) under BLA761069, with priority review for efficacy and ongoing labeling updates through 2026.
Regulatory Updates
Sep 2, 2026•1 min read
FDA Approves Pfizer/Astellas Padcev and Merck Keytruda Combo for All MIBC Patients
The FDA has approved the Padcev and Keytruda combination as the first muscle‑invasive bladder cancer therapy usable irrespective of cisplatin eligibility, for both neoadjuvant and adjuvant settings.
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Regulatory Updates
Aug 31, 2026•1 min read
Keytruda gains two Korean approvals, adds bladder, ovarian uses
MSD Korea received MFDS approval for two additional Keytruda combination therapy indications, bringing its Korean portfolio to 5 bladder and 2 ovarian cancer indications, covering 18 cancers and 37 indications overall.