May 11, 2026
The FDA has accepted for review a supplemental application for taletrectinib in advanced ROS1-positive NSCLC, with a PDUFA date of January 4, 2027. Updated TRUST-I and TRUST-2 data showed high response rates, durable responses and no new safety signals.
Mar 28, 2026
Sacituzumab tirumotecan demonstrated a median overall survival of 20.0 months versus 13.5 months with docetaxel in pretreated EGFR-mutated NSCLC patients. The phase 2 OptiTROP-Lung03 study showed a hazard ratio of 0.63 for overall survival benefit with the TROP2-directed antibody-drug conjugate.
Mar 24, 2026
Sanofi has submitted a revised acquisition bid for Ocular Therapeutix ahead of pivotal Phase 3 trial results for AXPAXLI, a sustained-release treatment for wet AMD. The deal could position Sanofi to re-enter the ophthalmology market it previously abandoned. The acquisition would give Sanofi access to innovative hydrogel delivery technology with potential applications beyond eye disease.
Mar 23, 2026
The FDA has approved a monthly subcutaneous dosing schedule for Johnson & Johnson's Rybrevant Faspro for EGFR-mutated NSCLC, based on PALOMA-2 trial data showing 82-87% response rates. The approval follows the drug's initial biweekly dosing approval in December 2025 and offers reduced administration time and reactions compared to intravenous delivery.
Mar 04, 2026
Ocular Therapeutix's Axpaxli outperformed low-dose Eylea in a Phase 3 trial for wet AMD, while Oculis Holding reported narrowed Q4 losses and expects Phase 3 trial readouts for OCS-01 in Q2 2026.
Mar 02, 2026
Phase III trial demonstrates belzutifan plus lenvatinib significantly improved progression-free survival versus cabozantinib in previously treated renal cell carcinoma patients, while neoadjuvant studies show promise for locally advanced disease.
Feb 28, 2026
New CAR T-cell approaches targeting BCMA and CD19 simultaneously show encouraging early results, while researchers develop control strategies for CAR-T therapies including antibody-drug conjugates.
Feb 21, 2026
West Virginia University Cancer Institute has dosed the first patient in a phase 1/2 trial evaluating subcutaneous blinatumomab for CD19-positive mixed-phenotype acute leukemia, a rare disease with no FDA-approved therapies. The first patient achieved complete remission after one cycle.
Feb 23, 2026
Ocular Therapeutix announced positive topline results from the SOL-1 Phase 3 superiority trial of AXPAXLI for wet age-related macular degeneration, meeting its primary endpoint with statistically significant improvements in vision outcomes compared to aflibercept.
Feb 17, 2026
Ocular Therapeutix's Axpaxli met its primary endpoint in the SOL-1 Phase 3 trial, showing superior vision maintenance compared to aflibercept in wet AMD patients. The company plans to pursue FDA approval based on the results.
Feb 14, 2026
Ocular Therapeutix announced positive topline results from SOL-1, its Phase 3 superiority trial of AXPAXLI for wet age-related macular degeneration, meeting primary and durability endpoints with high statistical significance.