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Mar 05, 2026
Whole genome sequencing, comprehensive genomic profiling, and spatial multiomics are transforming precision medicine from research tools to clinical applications in oncology, rare diseases, and neonatal care, enabling faster diagnoses and personalized treatments.
Mar 03, 2026
Relay Therapeutics reported full-year 2025 revenue of $15.36 million and a narrowed net loss of $276.48 million, while securing FDA Breakthrough Therapy designation for lead asset zovegalisib. The company filed a $96.18 million shelf registration.
Mar 02, 2026
AIM ImmunoTech partners with Thermo Fisher to design Phase 3 trial for Ampligen in pancreatic cancer, while Innovent Biologics begins dosing patients in Phase 3 study of IBI354 for HER2-positive breast cancer.
Mar 01, 2026
New ASCO guideline emphasizes biomarker-driven treatment for advanced gastroesophageal cancer, recommending upfront testing for HER2, PD-L1, MSI/MMR, and CLDN18.2 to guide immunotherapy and targeted therapy selection.
Feb 27, 2026
ALX Oncology reported fourth quarter and full year 2025 financial results, highlighting validation of CD47 as a predictive biomarker for evorpacept in HER2-positive cancers and progress in its ALX2004 EGFR-targeted ADC program.
Feb 24, 2026
The FDA has granted fast track designation to ART6043 plus olaparib for germline BRCA-mutated HER2-negative breast cancer and to BriaCell's Bria-IMT plus immune checkpoint inhibitor for metastatic breast cancer, both addressing significant unmet medical needs.
Feb 21, 2026
The FDA approved acalabrutinib plus venetoclax as the first all-oral, fixed-duration BTK inhibitor regimen for CLL/SLL and cleared monthly dosing for amivantamab in EGFR-mutated NSCLC. Additional regulatory reviews are underway for PCNSL and breast cancer treatments.
Feb 25, 2026
Greenwich LifeSciences announced acceptance of two abstracts for presentation at the AACR Annual Meeting 2026, including the first abstract co-authored with the full FLAMINGO-01 Steering Committee. The conference will be held April 17-22, 2026.
Feb 26, 2026
AstraZeneca's CALQUENCE received FDA approval as the first all-oral, fixed-duration regimen for chronic lymphocytic leukemia, while the EMA validated the marketing authorization application for ENHERTU in HER2-positive breast cancer treatment.
Feb 24, 2026
A first-in-human trial shows individualized neoantigen mRNA vaccines generated multi-year T cell responses in early-stage TNBC patients, with 82.9% of targeted mutations eliciting measurable immune activation not detectable before vaccination.
Feb 24, 2026
Enhertu combined with pertuzumab received FDA approval for first-line treatment of HER2-positive metastatic breast cancer, marking the first new treatment in a decade. Real-world data show trastuzumab deruxtecan efficacy is consistent across patient subgroups.
Feb 24, 2026
Vir Biotechnology reported Q4 EPS of ($0.31), beating estimates by $0.23, with revenue of $64.07 million. The company announced a global strategic collaboration with Astellas for VIR-5500 and reported $781.6 million in cash and investments.
Feb 24, 2026
Vir Biotechnology announced a global strategic collaboration with Astellas for VIR-5500, a PSMA-targeted dual-masked T-cell engager for prostate cancer, and reported $781.6 million in cash and investments as of December 31, 2025.
Feb 23, 2026
Two clinical trials demonstrate efficacy of talimogene laherparepvec (T-VEC) oncolytic virus therapy in HER2-negative breast cancer and nonmelanoma skin cancers, with favorable safety profiles and durable responses in subset of patients.
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 has accepted Roche's new drug application for giredestrant in combination with everolimus for ER-positive, HER2-negative, ESR1-mutated breast cancer, with a decision expected by December 18, 2026.
Feb 20, 2026
Former Novartis executive John Tsai has been appointed global head of R&D at Daiichi Sankyo, replacing Ken Takeshita effective April 1. Tsai brings over 25 years of leadership experience in drug development.
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 19, 2026
AstraZeneca has completed a Phase IIb heart failure trial for AZD5462, finished a real-world breast cancer study in Brazil, and is recruiting for an observational COPD study in heart clinic patients.
