Related coverage linked through entity extraction aliases.
Apr 27, 2026
The FDA approved Keytruda and Keytruda Qlex with paclitaxel, with or without bevacizumab, for PD-L1-positive platinum-resistant ovarian-related cancers. The Phase III KEYNOTE-B96 trial showed improved progression-free and overall survival versus placebo.
Apr 23, 2026
January and March 2026 drug pipeline updates included Phase 3 results, Fast Track designations and Priority Review decisions across multiple disease areas. Mavacamten, teplizumab-mzwv, anifrolumab, AXS-05, gedatolisib and AFTX-201 were among the programs with notable milestones.
Apr 08, 2026
ALX Oncology has multiple 2026 catalysts for Evorpacept and ALX2004. Interim ASPEN-09 data are expected in Q3 2026, while an initial safety update from the phase 1 ALX2004 trial is expected in 1H 2026.
Apr 07, 2026
A retrospective study of 692 matched HNSCC trials found that sponsor-driven decisions and poor recruitment were the leading causes of early termination. The analysis also identified enrollment, funding source, trial phase, and inclusion of procedures or surgery as factors associated with failure.
Mar 26, 2026
The FDA has approved Agilent's PD-L1 IHC 22C3 pharmDx as a companion diagnostic for identifying esophageal cancer patients eligible for Merck's KEYTRUDA immunotherapy. This marks the eighth FDA-approved indication for this diagnostic test with KEYTRUDA. The test helps identify patients whose tumors express PD-L1 for potential treatment with the anti-PD-1 therapy.
Mar 25, 2026
Diamyd Medical anticipates March 2026 interim results from its Phase 3 diabetes trial that could support a BLA pathway. Capricor Therapeutics awaits an August 2026 FDA decision on its Duchenne muscular dystrophy treatment BLA. Bicara Therapeutics prepares for Phase 3 study initiation of its oncology candidate toward future BLA submission.
Mar 23, 2026
Percheron Therapeutics outlines its phase II development strategy for HMBD-002, a VISTA-targeting immuno-oncology drug. The company reports favorable phase I safety data and plans an adaptive, multi-arm phase II trial starting in 2026. HMBD-002 is designed as a next-generation checkpoint inhibitor with potential to overcome limitations of existing therapies.
Mar 13, 2026
Meta-analysis of 23 trials finds neoadjuvant chemoimmunotherapy achieved 66% major pathologic response in head and neck cancer patients compared to 18% for dual-agent and 6% for single-agent immunotherapy, though survival impact remains unclear.
Feb 18, 2026
The U.S. FDA granted Breakthrough Therapy Designation for subcutaneous Rybrevant Faspro as monotherapy for adults with advanced head and neck squamous cell carcinoma, based on Phase 1b/2 study data showing rapid and durable responses.
Feb 17, 2026
The FDA has approved a monthly dosing schedule for Rybrevant Faspro in EGFR-mutated NSCLC and granted breakthrough therapy designation for the drug as monotherapy in HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma after prior therapy.
Dec 18, 2025
The FDA approved a once-monthly dosing schedule for Rybrevant Faspro with Lazcluze for first-line treatment of EGFR-mutated advanced NSCLC, reducing clinic visits while maintaining safety and efficacy established with bi-weekly dosing.
