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Feb 24, 2026
AIM ImmunoTech outlined key milestones for its Phase 2 DURIPANC trial evaluating Ampligen combined with durvalumab in metastatic pancreatic cancer, with primary endpoint evaluation expected in December 2026.
Feb 23, 2026
The FDA approved the combination of acalabrutinib and venetoclax as the first all-oral, fixed-duration regimen for adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma, based on Phase 3 AMPLIFY trial results.
Feb 20, 2026
The FDA has approved a supplemental new drug application for the combination regimen of Venclexta (venetoclax) and acalabrutinib for previously untreated adult patients with chronic lymphocytic leukemia, supported by Phase 3 AMPLIFY trial data.
Feb 20, 2026
FDA approves AstraZeneca's Calquence plus venetoclax as first all-oral, 14-month fixed-duration regimen for first-line chronic lymphocytic leukemia, with 77% of patients progression-free at three years in Phase III trial.
Nov 17, 2025
The FDA has accepted Celcuity's New Drug Application for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer, granting Priority Review with a PDUFA goal date of July 17, 2026.
Feb 17, 2026
New clinical trial data show trastuzumab deruxtecan plus pertuzumab extends progression-free survival as first-line therapy, while MRI-guided treatment shortening reduces toxicity in neoadjuvant settings for HER2-positive breast cancer.
Feb 20, 2026
The FDA approved AbbVie's combination of Venclexta and acalabrutinib as the first all-oral, fixed-duration treatment for previously untreated chronic lymphocytic leukemia patients, based on Phase 3 trial data showing 35% reduction in disease progression risk.
Feb 20, 2026
The FDA approved acalabrutinib plus venetoclax as the first all-oral, fixed-duration regimen for previously untreated chronic lymphocytic leukemia, based on phase III AMPLIFY trial results showing 35% reduction in disease progression or death risk versus chemoimmunotherapy.
Feb 20, 2026
The FDA has accepted Roche's New Drug Application for giredestrant plus everolimus to treat ESR1-mutated, ER-positive advanced breast cancer, with a decision expected by December 18, 2026. The filing is based on phase III data showing significant reductions in disease progression risk.
Feb 20, 2026
PDS Biotechnology adopted an amended protocol for its Phase 3 VERSATILE-003 trial, adding progression-free survival as an interim primary endpoint to support potential accelerated approval of PDS0101 in HPV16-positive head and neck cancer.
Feb 14, 2026
Retrospective analysis of the ZUMA-2 trial found that previous ibrutinib exposure was associated with improved progression-free survival after brexucabtagene autoleucel treatment in mantle cell lymphoma patients, though with increased toxicity.
Feb 20, 2026
The FDA has approved the combination of acalabrutinib and venetoclax as the first all-oral, fixed-duration BTK inhibitor-based regimen for previously untreated adult patients with chronic lymphocytic leukemia and small lymphocytic lymphoma.
Feb 20, 2026
The FDA has accepted a new drug application for giredestrant plus everolimus for ESR1-mutated, ER-positive, HER2-negative advanced breast cancer, with a decision expected by December 18, 2026. The phase 3 evERA study showed a 62% reduction in disease progression or death risk in ESR1-mutated patients.
Feb 20, 2026
The FDA has accepted Roche's new drug application for oral SERD giredestrant in ESR1-mutated, ER-positive advanced breast cancer, with a decision expected by December 18, 2026. The filing is restricted to the ESR1-mutant population despite phase 3 trial benefits in broader patients.
Feb 20, 2026
The FDA has approved the combination of Venclexta (venetoclax) plus acalabrutinib as the first all-oral, fixed-duration regimen for previously untreated adults with chronic lymphocytic leukemia, based on Phase III AMPLIFY study results.
Feb 19, 2026
The FDA has accepted for Priority Review Bristol Myers Squibb's New Drug Application for iberdomide in combination with daratumumab and dexamethasone for relapsed or refractory multiple myeloma, with a target decision date of August 17, 2026.
Feb 18, 2026
NovaBridge Biosciences has enrolled the first patient in a global Phase 2 study evaluating givastomig in combination with nivolumab and chemotherapy for HER2-negative, first-line metastatic gastric cancer, with top-line results expected in 2027.
Feb 17, 2026
Pfizer announced positive progression-free survival results from the BREAKWATER trial evaluating Braftovi in combination with cetuximab and Folfiri in previously untreated metastatic colorectal cancer patients with BRAF V600E mutation.
Feb 18, 2026
The FDA has accepted a new drug application for tirabrutinib, a BTK inhibitor, for relapsed/refractory primary central nervous system lymphoma under the accelerated approval pathway. The regulatory agency set a PDUFA target action date of December 18, 2026.
Feb 17, 2026
Oncolytics Biotech received FDA Fast Track Designation for pelareorep in second-line KRAS-mutant microsatellite-stable metastatic colorectal cancer, based on clinical data showing a 33% response rate and median overall survival of 27 months versus 11.2 months with standard treatment.
