02/06/2026 FDA accepts NDA and grants priority review to Roche’s giredestrant for early-stage ER+, HER2- breast cancer Candel’s CAN‑2409 Phase 3 in localized prostate cancer shows significant DFS benefit with favorable safety, supporting BLA filing in Q4 2026 Cycle Pharma secures FDA approval for CAVHANZA™, the first nilotinib ODT eliminating PPI/H₂RA timing restrictions to broaden Ph+ CML treatment flexibility FDA accepts NDA and grants priority review to Roche’s giredestran

31/05/2026 Johnson & Johnson submits US sBLA for subcutaneous amivantamab in HPV-unrelated R/M HNSCC, previously treated with immunotherapy and chemotherapy Johnson & Johnson submits US sBLA for subcutaneous amivantamab in HPV-unrelated R/M HNSCC, previously treated with immunotherapy and chemotherapy (Ref) Johnson & Johnson confirmed that a supplemental Biologics License Application (sBLA) has been submitted to the US FDA seeking approval of subcutaneous amivantamab (EGFR x

07/05/2026 Pierre Fabre secures FDA alignment to resubmit tabelecleucel BLA with updated ALLELE Phase 3 data for EBV+ PTLD Halozyme Announces Global Collaboration and License Agreement with GSK for the first ADC-focused ENHANZE, targeting subcutaneous oncology formulations and milestone-driven royalties Pierre Fabre secures FDA alignment to resubmit tabelecleucel BLA with updated ALLELE Phase 3 data for EBV+ PTLD (Ref) Pierre Fabre Pharmaceuticals (PFP) aligned with the FDA o

13/04/2026 FDA issues Complete Response Letter to Replimune’s RP1 BLA, halting accelerated approval path FDA Grants Priority Review for Ifinatamab Deruxtecan in ES-SCLC Daraxonrasib Demonstrates Unprecedented Survival Benefit in Phase 3 Pancreatic Cancer Trial Jaypirca (pirtobrutinib) combination significantly extended progression-free survival (PFS) in Relapsed/Refractory CLL/SLL SynOx Therapeutics' Phase 3 TANGENT Study Delivers Positive Results for TGCT Treatment IDEAYA an

12/01/2026 Novita Pharmaceuticals' NP-G2-044 received the FDA orphan drug designation for pancreatic cancer Eureka Therapeutics' ECT204 received the FDA RMAT designation for hepatocellular carcinomaEureka Therapeutics' ECT204 received the FDA RMAT designation for hepatocellular carcinoma Summit Therapeutics submitted a BLA seeking approval for ivonescimab + chemo in 2L+ EGFRm NSCLC AbbVie acquires ex-China rights to RemeGen's RC148 in a ~$5.6B deal Novita Pharmaceuticals' NP-

11/12/2025 BMS' sBLA for Opdivo + AVD received the FDA priority review for first-line cHL BMS' sBLA for Opdivo + AVD received the FDA priority review for first-line cHL ( Ref ) The US FDA granted priority review status to Bristol Myers Squibb's sBLA for nivolumab (Opdivo; anti-PD-1) + doxorubicin, vinblastine and dacarbazine (AVD) for adult and pediatric (12 years and older) patients with previously untreated stage III or IV classical Hodgkin Lymphoma (cHL). The FDA assigned