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
Frontier to reveal first FMC-376 clinical responses in KRAS G12C lung cancer
Frontier Medicines will present its first Phase 1 clinical findings for FMC-376 at ESMO 2026, including preliminary responses in patients previously treated with KRAS G12C inhibitors. The investigational drug targets both active and inactive KRAS G12C, but detailed response rates and patient counts remain undisclosed ahead of the presentation.
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
Why the PD-L1-high subgroup could be crucial for Summit Therapeutics’ global strategy
Summit shares rise after ivonescimab delivers 30.8-month survival versus 22.6 months for pembrolizumab in China’s HARMONi-2 trial.
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
Lytix moves ruxotemitide toward registrational melanoma trial after FDA backs EFS endpoint
FDA raised no objection to a randomized Phase 3 comparing neoadjuvant ruxotemitide plus pembrolizumab with pembrolizumab alone and indicated that one well-controlled study could potentially support an NDA.
Pharma & Biotech
Phanes Therapeutics advances CLDN18.2 and CD47 bispecific spevatamig in biliary tract cancer
FDA Fast Track gives spevatamig a faster regulatory path in biliary tract cancer as Phanes advances its Phase 2 and pembrolizumab strategy.
Pharma & Biotech
Why Kelun-Biotech’s latest sac-TMT Phase III result could matter more than the headline suggests
Kelun-Biotech reports improved Phase III PFS with sac-TMT plus pembrolizumab, while survival and detailed safety data remain pending.
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.