Gilead’s Trodelvy cleared a key EU hurdle, but can it really replace chemotherapy in first-line TNBC?
CHMP backs Trodelvy plus Keytruda for first-line PD-L1-positive metastatic TNBC, moving Gilead closer to an expanded EU label.
Pharma & Biotech
Pharma & Biotech
Multikine is back in Phase 3, but can CEL-SCI turn a striking subgroup signal into approval?
CEL-SCI launches a 212-patient Multikine Phase 3 study, but subgroup validation, funding and regulatory execution remain decisive.
Pharma & Biotech
Can Keytruda plus Padcev replace cisplatin chemotherapy before bladder cancer surgery?
FDA approval moves Keytruda and Padcev into perioperative MIBC regardless of cisplatin eligibility, intensifying the contest for standard care.
Pharma & Biotech
Pfizer and Astellas secure wider FDA label for Padcev plus Keytruda in muscle-invasive bladder cancer
FDA expands Padcev plus Keytruda to adults with muscle-invasive bladder cancer regardless of cisplatin eligibility, reshaping perioperative care.
Pharma & Biotech
Samsung Bioepis SB27 meets Phase 3 endpoint as Keytruda biosimilar competition accelerates
Read how Samsung Bioepis SB27’s positive Phase 1 and Phase 3 data could reshape the Keytruda biosimilar race and oncology access.
Pharma & Biotech
Merck and Gilead secure FDA approval for a new ADC-immunotherapy backbone in advanced TNBC
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.
Pharma & Biotech
Gilead expands Trodelvy into first-line metastatic TNBC, but survival questions remain 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.
Pharma & Biotech
Merck moves Welireg earlier as FDA clears Keytruda combinations in high-risk ccRCC
Find out how Merck’s Keytruda and Welireg approval could reshape adjuvant clear cell renal cell carcinoma treatment.
Pharma & Biotech
Gilead and Merck pipeline update reveals promise in HIV and pressure in oncology
Gilead and Merck gain HIV momentum but face fresh oncology questions. See why this split pipeline update matters.
Medical Devices & Diagnostics
Agilent wins FDA backing to move more Keytruda-linked PD-L1 testing onto Dako Omnis
Find out how Agilent’s expanded PD-L1 test approval could change automated cancer diagnostics and oncology lab workflows.