Gilead Sciences has secured U.S. Food and Drug Administration approval for Bixlenvo, a once-daily tablet combining bictegravir and lenacapavir for virologically suppressed adults with HIV, including patients whose resistance or treatment history has kept them on complex multi-tablet regimens.
FairJourney Bio engineers a tumor-conditional IL-12 switch designed to limit systemic exposure and localize cytokine activation in solid tumors.
EU approval moves Datroway into first-line metastatic TNBC after TROPION-Breast02 showed survival gains, intensifying the TROP2 ADC race.
Atea’s eight-week bemnifosbuvir and ruzasvir regimen matched 12-week Epclusa in a 905-patient Phase 3 hepatitis C trial.
ViiV Healthcare’s VOGUE trial found Dovato non-inferior to Biktarvy at Week 48, sharpening the debate over two-drug first-line HIV care.
CHMP backs Trodelvy plus Keytruda for first-line PD-L1-positive metastatic TNBC, moving Gilead closer to an expanded EU label.
Arcus Biosciences will report Q2 results on August 5 as investors assess casdatifan progress, pipeline execution and its cash runway.
Gilead and Merck’s weekly HIV pill preserved suppression in two Phase 3 trials, strengthening the case for regulatory filings.
The new regimen replaces conventional chemotherapy with a Trop-2-directed antibody-drug conjugate while retaining PD-1 blockade, offering longer disease control but leaving overall survival, sequencing and cost questions unresolved.
The decision gives clinicians a Trodelvy-based option for patients who cannot receive checkpoint inhibitors and a Trodelvy plus Keytruda regimen for PD-L1-positive disease. The immediate clinical impact is substantial, although immature overall-survival data, toxicity management and treatment cost will influence how rapidly the new pathways displace chemotherapy.