Merck and Moderna report 42% lower melanoma recurrence risk in Phase 3 mRNA trial
Merck and Moderna report 42% lower melanoma recurrence risk with intismeran plus Keytruda. Survival, safety and manufacturing remain key.
Pharma & Biotech
Pharma & Biotech
Zydus gains regulatory milestone in $31.7bn Keytruda biosimilar market
The FDA has accepted FYB206, a proposed biosimilar to Merck's Keytruda, for review, with a decision potentially due in the third quarter of 2027. Zydus and Formycon pursued a streamlined development programme without a comparative Phase 3 efficacy trial, but approval, patent clearance and commercial launch remain separate hurdles.
Pharma & Biotech
Merck’s Keytruda-Padcev bladder cancer push moves closer to broader EU approval
Merck & Co.’s Keytruda plus Padcev has won a positive European regulatory opinion for perioperative treatment of resectable muscle-invasive bladder cancer regardless of cisplatin eligibility, potentially expanding an already important oncology franchise into a broader earlier-stage population.
Pharma & Biotech
Keytruda generated $31.6bn last year. Cipla and Qilu are positioning a biosimilar for the U.S. market
Cipla’s Invagen has licensed U.S. rights to Qilu’s investigational pembrolizumab biosimilar QL2107, setting up a future challenge to Merck’s blockbuster Keytruda franchise.
Pharma & Biotech
Moderna and Merck’s personalized mRNA cancer therapy clears Phase 3 test, but the numbers still matter
INTerpath-001 met recurrence-free and distant metastasis-free survival endpoints in 1,137 patients, giving individualized mRNA cancer therapy its first positive Phase 3 readout.
Pharma & Biotech
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
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.