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.
KEYTRUDA | 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.
Keytruda | 08/05/2026 | By News Bureau | 144
Citius Oncology reports positive Phase I data showing encouraging safety and response rates for LYMPHIR combined with Keytruda in recurrent gynecologic cancers, supporting further Phase II evaluation.
Keytruda | 11/03/2026 | By News Bureau | 122
Merck reports positive Phase III results for Keytruda and Welireg combination in kidney cancer
Phase III LITESPARK-022 trial shows Keytruda plus Welireg significantly improves disease-free survival in patients with clear cell renal cell carcinoma after surgery, reducing recurrence or death risk by 28 percent.
Keytruda | 05/03/2026 | By News Bureau | 142
Biocon Biologics to Showcase Keytruda and Two New Oncology Biosimilars at JPM 2026
Biocon Biologics, the biosimilars arm of Biocon Ltd, is set to introduce three new oncology biosimilars, including a biosimilar of pembrolizumab (Keytruda), at the J.P. Morgan Healthcare Conference 2026 in San Francisco.
Keytruda | 07/01/2026 | By Darshana | 340
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.
Keytruda | 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.
KEYTRUDA | 18/12/2025 | By News Bureau | 151
FDA Approves Diagnostic Tool for Pembrolizumab Combo in Endometrial Cancer
The US FDA has cleared the OncoMate MSI Dx Analysis System as a companion diagnostic to guide pembrolizumab-based combination therapy in advanced endometrial cancer. The PCR-based assay determines microsatellite instability (MSI) status in tumour tissue, with support from Merck, developer of pembrolizumab and lenvatinib.
Keytruda | 15/11/2025 | By Dineshwori | 310
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.
KEYTRUDA | 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.
KEYTRUDA | 11/10/2025 | By Dineshwori | 923
We use our own and third party cookies to produce statistical information and show you personalized advertising by analyzing your browsing, according to our COOKIES POLICY. If you continue visiting our Site, you accept its use.
More information: Privacy Policy