US FDA Grants Breakthrough Therapy Designation to Calderasib for KRAS G12C-Mutant NSCLC
Calderasib has received US FDA Breakthrough Therapy Designation for certain patients with newly diagnosed metastatic KRAS G12C-mutant Non-Small Cell Lung Cancer (NSCLC), supported by promising phase 1 KANDLELIT-001 trial data highlighting its potential as a next-generation, highly potent and selective KRAS G12C inhibitor.
Pembrolizumab | 30/05/2026 | By News Bureau
Samsung Bioepis achieves positive Phase 1 results for Keytruda biosimilar candidate SB27
The biopharmaceutical company announced that its proposed pembrolizumab biosimilar, SB27, met primary pharmacokinetic endpoints in a global Phase 1 study involving non-small cell lung cancer patients, advancing its oncology biosimilar pipeline.
Pembrolizumab | 08/05/2026 | By News Bureau | 144
Zydus Partners with Bioeq for US Commercialisation of Lucentis Biosimilar
Zydus has entered into a partnership with Bioeq to commercialise NUFYMCO, an interchangeable biosimilar to Lucentis, in the US market. Under the agreement, Bioeq will handle development, manufacturing, regulatory approval and product supply, while Zydus will oversee US commercialisation.
Pembrolizumab | 24/12/2025 | By News Bureau | 160
KEYTRUDA Plus Padcev Improves Survival Outcomes in MIBC
KEYTRUDA plus Padcev significantly improved survival and pathologic complete response rates in cisplatin-eligible patients with muscle-invasive bladder cancer when used before and after surgery.
Pembrolizumab | 18/12/2025 | By News Bureau | 151
Formycon, MS Pharma Ink MENA Deal for Keytruda Biosimilar FYB206
Formycon has signed an exclusive commercialisation agreement with MS Pharma for its Keytruda biosimilar candidate FYB206 in the MENA region. The deal includes an upfront payment, milestone-based fees, and a significant share of regional gross profits generated in the region.
Pembrolizumab | 05/12/2025 | By Dineshwori | 126
EU Approves KEYTRUDA for PD-L1+ Resectable Head and Neck Cancer
KEYTRUDA monotherapy has been approved for use as a neoadjuvant treatment, followed by adjuvant therapy in combination with radiotherapy with or without cisplatin, and continued thereafter as maintenance monotherapy.
Pembrolizumab | 30/10/2025 | By Dineshwori | 221
Merck is set to showcase new data at ESMO 2025, highlighting advancements in oncology across emerging tumor types and early-stage diseases, with positive survival results from KEYNOTE-905 and KEYNOTE-B96 trials demonstrating the impact of KEYTRUDA (pembrolizumab) in bladder and ovarian cancers.
Pembrolizumab | 11/10/2025 | By Dineshwori | 923
BerGenBio Begins Phase 2a in First Line NSCLC Patients with STK11m
BerGenBio ASA has initiated Phase 2a portion of the BGBC016 clinical study of its selective AXL inhibitor bemcentinib in combination with standard of care therapy in first-line Non-Small Cell Lung Cancer (NSCLC) patients
Pembrolizumab | 21/03/2024 | By Manvi | 644
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