Newly FDA-Approved REVTORPYK™ (gedatolisib) Included in the NCCN Clinical Practice Guidelines for HR+/HER2- Locally Advanced or Metastatic Breast Cancer August 5, 2026
Enhertu + pertuzumab recommended for approval in the EU by CHMP in 1L HER2-positive metastatic breast cancer July 28, 2026
FDA accepts NDA for Daraxonrasib for Review for Previously Treated Metastatic Pancreatic Cancer July 28, 2026
Supplemental Application accepted for Toripalimab + Chemo as Perioperative Treatment for Resectable Stage II-III NSCLC July 28, 2026
FDA Grants Priority Review for TALZENNA Plus XTANDI for the Treatment of Metastatic Prostate Cancer July 28, 2026
Jaypirca (pirtobrutinib) recommended by CHMP for approval in the EU for adults with CLL across all lines of therapy July 21, 2026
FDA Provides Written Feedback on NEO212 CMC Development and Capsule-to-Tablet Transition July 21, 2026
FDA Accepts NDA for Mezigdomide in Patients with Relapsed or Refractory Multiple Myeloma; PDUFA: May 2027 July 15, 2026
FDA sends CRL for Combination of Rivoceranib and Camrelizumab as 1L Treatment for Unresectable or Metastatic HCC July 15, 2026
FDA Clears IND Application for LTZ-232 to Treat Advanced Metastatic CRC and Other Solid Tumors July 15, 2026
HETRONIFLY (serplulimab) recommended by the NICE for routine use within the NHS in England and Wales July 7, 2026
Datroway recommended for approval in the EU by CHMP for patients with 1L metastatic TNBC who are not candidates for immunotherapy June 30, 2026
BfArM Approval to Initiate Ph 2/3 Trial of SIL204 in Locally Advanced Pancreatic Cancer June 30, 2026
