US FDA Approves PADCEV Plus Keytruda for Muscle-Invasive Bladder Cancer
The US Food and Drug Administration (FDA) has approved PADCEV plus Keytruda as the first and only platinum-free neoadjuvant and adjuvant treatment for adults with Muscle-Invasive Bladder Cancer (MIBC), regardless of cisplatin eligibility.
Pembrolizumab | 13/07/2026 | By News Bureau
US FDA Approves KEYTRUDA and KEYTRUDA QLEX, Each with Trodelvy
The US Food and Drug Administration (FDA) has approved KEYTRUDA and KEYTRUDA QLEX in combination with Trodelvy as first-line treatment for adults with PD-L1-positive (CPS ≥10) advanced Triple-Negative Breast Cancer (TNBC).
Pembrolizumab | 26/06/2026 | By News Bureau | 179
US FDA Approves KEYTRUDA-WELIREG Combination for Adjuvant ccRCC
The US Food and Drug Administration (FDA) has approved KEYTRUDA and KEYTRUDA QLEX in combination with WELIREG for the adjuvant treatment of certain patients with clear cell Renal Cell Carcinoma (ccRCC). The approval expands treatment options for kidney cancer patients at high risk of recurrence following surgery.
Pembrolizumab | 15/06/2026 | By News Bureau
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 | 111
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 | 180
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 | 181
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 | 177
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 | 148
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 | 234
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 | 968
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