Regulatory Timeline
FDA, EMA, PMDA, and other regulatory milestones from linked signals and precedents.
LillyJun 14, 2026mid-term
Lilly presents promising Phase 1 data for first-in-class type II JAK2 inhibitor in myelofibrosis
The encouraging safety profile and clinical activity may facilitate a smoother path to regulatory approval, but ongoing monitoring of data and filings will be essential.
View detailFDAJun 15, 2026safety_guidance
FDA AP — EMGALITY (SUPPL)
Application BLA761063. Sponsor: ELI LILLY AND CO. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: GALCANEZUMAB-GNLM.
View detailFDAJun 15, 2026safety_guidance
FDA AP — EBGLYSS (SUPPL)
Application BLA761306. Sponsor: ELI LILLY AND CO. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: LEBRIKIZUMAB-LBKZ.
View detailFDAJun 15, 2026safety_guidance
FDA AP — EMGALITY (SUPPL)
Application BLA761063. Sponsor: ELI LILLY AND CO. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: GALCANEZUMAB-GNLM.
View detailMHRAJun 15, 2026approval
Clinical trials for medicines: modifying a clinical trial approval
Guidance on the various types of modifications that can be made to a clinical trial approval.
View detailFDAJun 15, 2026safety_guidance
Janus Kinase (JAK) inhibitors: Drug Safety Communication - FDA Requires Warnings about Increased Risk of Serious Heart-related Events, Cancer, Blood Clots, and Death
FDA is requiring revisions to the Boxed Warning, FDA’s most prominent warning, for Xeljanz/Xeljanz XR, Olumiant, and Rinvoq to include information about the risks of serious heart-related events, cancer, blood clots, and death.
View detailLillyJun 15, 2026mid-term
Lilly's Jaypirca shows 45% reduction in disease progression risk in CLL/SLL
The trial results may influence regulatory discussions and approvals, particularly if further data supports the efficacy of Jaypirca in combination therapies.
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