Can Samsung Bioepis challenge Keytruda after its U.S. patent cliff begins in 2028?
Samsung Bioepis matched Keytruda in Phase 3, but an earlier FDA filing and Keytruda Qlex complicate the coming biosimilar battle.
Features & Analysis
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
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
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.