FDA Accepts NDA for Vepdegestrant for the Treatment of ESR1m, ER+/HER2- Advanced Breast Cancer August 12, 2025
SOPHiA GENETICS expands collaboration with AstraZeneca using AI to improve breast cancer patient outcomes August 12, 2025
Regulatory Clearance obtained to Initiate Ph 1 Trial for PQ203 in the U.S. and Canada; FDA Fast Track Designation Granted August 11, 2025
Positive FDA Feedback and Advances Toward IND for (Z)-Endoxifen Clinical Program in ER+/HER2- Metastatic Breast Cancer Announced August 5, 2025
Clinically Meaningful Improvement in Both PFS Primary Endpoints from PIK3CA WT Cohort of Ph 3 VIKTORIA-1 Trial Announced July 29, 2025
European Commission approves Itovebi for people with ER+ve HER2neg advanced breast cancer with a PIK3CA mutation July 29, 2025
Preliminary topline efficacy results from Ph 2 TRIFOUR trial of nadunolimab in advanced TNBC announced July 23, 2025
ENHERTU + Pertuzumab Granted Breakthrough Therapy Designation in the US as 1L Therapy for Patients with HER2+ve Metastatic Breast Cancer July 23, 2025
Early Efficacy Data Reported from First TNBC Patient Receiving Paxalisib Combination Regimen achieving >50% Reduction in CTCs in Ph 1b Trial July 15, 2025
Pelareorep Survival Data in Multiple Tumors and Commitment to Registration-Enabling Studies announced July 15, 2025
Patient Achieves Sustained Complete Resolution of Lung Metastasis in Bria-OTS Metastatic Breast Cancer Study July 15, 2025
Bria-IMT Demonstrates Survival Advantage over Trodelvy® and Control Group in Metastatic Breast Cancer July 15, 2025
Data from Ongoing Dose Escalation of BA3182 in Patients with Treatment Refractory Metastatic Adenocarcinoma presented July 8, 2025
Austrian Regulatory Green Light Enables ADC Combination Testing and Ph 1 Site Expansion for ES2B-C001 July 8, 2025
Gilead Sciences and Kymera Therapeutics Enter Into Exclusive Option and License Agreement to Develop Novel Oral Molecular Glue CDK2 Degraders July 1, 2025
Preliminary data announced for gedatolisib from Ph 1 CELC-G-201 trial in metastatic CRPC and Ph 2 HER2+ metastatic breast cancer patients July 1, 2025
Results from Ph 1/2 Study of Sacituzumab Tirumotecan (sac-TMT) in Solid Tumors Refractory to Standard Therapies Published in Journal of Hematology & Oncology June 17, 2025
FDA authorizes Expanded Access Program for MNPR-101-Zr and MNPR-101-Lu in Advanced Cancers June 17, 2025
NDA submitted to U.S. FDA for Vepdegestrant for Patients with ESR1-Mutated ER+/HER2- Advanced or Metastatic Breast Cancer June 11, 2025
Ph 1/2 trial of AVZO-023 initiated in patients with advanced or metastatic HR+/HER2- breast cancer and select other advanced solid tumors June 10, 2025
CHMP recommends EU approval of Itovebi for PIK3CA-mutated, ER+ve, HER2-neg, advanced breast cancer May 27, 2025