Olomorasib receives FDA Breakthrough Therapy designation for the treatment of previously treated KRAS G12C-mutant advanced pancreatic cancer August 5, 2026
FDA Clearance to Initiate TEMPO-1 Registrational Study of CRB-701 in Patients with 2L Oropharyngeal Cancer Announced August 5, 2026
RYBREVANT FASPRO (amivantamab & hyaluronidase-lpuj) receives FDA Priority Review for EGFR- & MET-targeted subQ treatment for advanced head and neck cancer August 5, 2026
IND Application for Ph 1b/2 Opamtistomig Combo in Metastatic Colorectal Cancer Approved August 5, 2026
FDA Grants Orphan Drug Designation to Zocilurtatug Pelitecan (Zoci) for the Treatment of Neuroendocrine Carcinomas (NECs) August 5, 2026
FDA RMAT Designation for Cemacabtagene Ansegedleucel (Cema-Cel) as 1L Consolidation Therapy for LBCL August 5, 2026
Supplemental NDA submission for Selinexor Plus Ruxolitinib in Myelofibrosis Planned Under Accelerated Approval Pathway August 5, 2026
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
