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May 17, 2026
ImmunityBio said the Saudi FDA encouraged submission of a regulatory package for recombinant BCG and opened talks on expanding ANKTIVA with checkpoint inhibitors to additional tumor types. The company expects to file the rBCG package within weeks.
May 01, 2026
Crescent Biopharma dosed the first patient in its ASCEND Phase 1/2 trial of CR-001, a PD-1 x VEGF bispecific antibody for solid tumors. The company also reported Q1 2026 results and outlined pipeline milestones including ADC combination trials expected in the second half of 2026.
Apr 28, 2026
AbbVie filed an sBLA for SKYRIZI as a subcutaneous induction therapy for Crohn's disease, supported by Phase 3 AFFIRM data. SKYRIZI and Rinvoq combined for $25.9B in 2025 revenue, exceeding 2027 guidance. The FDA also approved Venclexta plus acalabrutinib in CLL.
Apr 20, 2026
Bayer’s sevabertinib has obtained domestic approval as an imported rare drug for HER2-mutant non-small cell lung cancer. The oral reversible HER2-targeted TKI was previously approved by the FDA for previously treated patients.
Apr 20, 2026
Updated phase I data showed zoldonrasib produced a 52% confirmed objective response rate and 93% disease control rate in previously treated KRAS G12D-mutant NSCLC. No grade 4 or higher treatment-related adverse events were observed at the recommended phase II dose.
Apr 19, 2026
Studies on immune checkpoint inhibitor therapy found pretreatment biomarkers strongly predicted checkpoint inhibitor-associated autoimmune diabetes, while hyperglycemia during treatment was common and did not worsen disease progression.
Apr 09, 2026
Ten-year follow-up of the phase 3 ESPATUE trial found similar overall and progression-free survival with chemoradiotherapy boost or surgery in resectable advanced NSCLC after induction therapy.
Apr 02, 2026
China's regulatory reforms since 2015 have streamlined clinical trial and drug approval processes, accelerating development of advanced therapies like CAR-T and bispecific antibodies. These changes have boosted investor confidence and created opportunities for global pharmaceutical partnerships with Chinese biotech companies that have innovative pipelines but lack international marketing capabilities.
Apr 02, 2026
FDA has cleared a robotic nipple-sparing mastectomy platform after clinical trials showed excellent results with preserved breast sensation. Researchers are advancing immunotherapy combinations for breast cancer and novel strategies to overcome drug resistance in EGFR-mutated lung cancer, including protein degraders and dual-binding inhibitors.
Apr 02, 2026
Pharmaceutical M&A is shifting toward late-stage clinical assets with proven human data, particularly in GLP-1 obesity drugs, oncology, and central nervous system disorders. Companies like Viking Therapeutics, Structure Therapeutics, and Revolution Medicines represent compelling acquisition targets with advanced clinical programs. This trend reflects industry prioritization of de-risked assets that can accelerate commercialization pathways.
Mar 28, 2026
The phase III TOP study shows osimertinib plus chemotherapy more than doubles progression-free survival to 34 months versus 15.6 months with osimertinib alone in EGFR/TP53 mutant NSCLC. The combination achieved an 82.9% response rate and represents a new strategy for this high-risk subgroup. Research continues into resistance mechanisms, including cancer-associated fibroblasts' role in promoting osimertinib resistance.
Mar 27, 2026
Despite guidelines recommending broad molecular profiling for precision oncology, biomarker testing faces significant implementation barriers including insurance coverage limitations, lengthy turnaround times, and tissue adequacy issues. Studies show most patients lack biomarker results at initial consultation, with up to 43% having insufficient tissue for genotyping in NSCLC cases.
Mar 24, 2026
Kelun-Biotech reported 2025 revenue of RMB2.06 billion with four products now marketed in China. The company's TROP2 ADC received multiple regulatory approvals for breast and lung cancer indications. A Phase 3 trial combining the ADC with pembrolizumab met its primary endpoint in first-line NSCLC treatment.
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 12, 2026
Recent studies reveal immunotherapy failed to improve survival in small-cell lung cancer when combined with chemoradiation, while timing of immunotherapy after radiation therapy affects outcomes in non-small cell lung cancer patients.
Mar 12, 2026
The FDA is accelerating its review of daraxonrasib, a targeted therapy for pancreatic cancer, under a new pilot program that could reduce approval time from 10-12 months to one to two months.
Mar 11, 2026
Researchers at the Regina Elena National Cancer Institute in Rome discovered how the hMENA protein enables non-small cell lung cancer to resist immunotherapy by regulating cancer-associated fibroblasts that create a protective tumor microenvironment.
Mar 11, 2026
Recent studies demonstrate PD-1 antibody combinations improve survival in natural killer/T-cell lymphoma and show activity in previously treated advanced non-small cell lung cancer, with manageable safety profiles across treatment settings.
Mar 11, 2026
AstraZeneca terminated its Phase I/IIa trial of AZD0022 for KRASG12D-mutant cancers, withdrew a planned saruparib ovarian cancer platform study, and completed a real-world non-small cell lung cancer treatment review.
Mar 10, 2026
Researchers unveil tumor-intrinsic role of PD-L1 in lung cancer progression and develop systematic method for discovering molecular glues that selectively degrade disease proteins, while advances in immunology research aim to improve care for immune-mediated inflammatory diseases.
