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RSS FeedPosted by Michael Wonder on 10 Jun 2026
Imugene's azer-cel granted FDA fast track designation for CLL/SLL and MZL
9 June 2026 - Imugene is pleased to announce that the US FDA has granted fast track designation to azer-cel ...
Posted by Michael Wonder on 05 Jun 2026
US FDA approves FoundationOne CDx as a companion diagnostic for Itovebi (inavolisib) to identify patients with hormone receptor positive, HER2 negative breast cancer with a PIK3CA mutation
2 June 2026 - Foundation Medicine today announced that it has received approval from the US FDA for FoundationOne CDx ...
Posted by Michael Wonder on 04 Jun 2026
Verastem Oncology announces US FDA fast track designation for VS-7375, an oral and potential best in class investigational KRAS G12D (ON/OFF) inhibitor for the treatment of KRAS G12D mutated locally advanced or metastatic non-small cell lung cancer
3 June 2026 - Verastem Oncology today announced that the US FDA has granted hast track designation to VS-7375, an oral ...
Posted by Michael Wonder on 02 Jun 2026
FDA accepts new drug application for Roche’s giredestrant in oestrogen receptor positive early-stage breast cancer, the first and only oral SERD with positive phase III results in the curative setting
2 June 2026 - Roche announced today that the US FDA has accepted the company’s new drug application under priority review ...
Posted by Michael Wonder on 01 Jun 2026
Nouscom receives US FDA fast track designation for NOUS-209, a novel immunotherapy for the prevention of Lynch syndrome-associated cancers
1 June 2026 - Nouscom today announced that the US FDA has granted fast track designation to NOUS-209 for the prevention ...
Posted by Michael Wonder on 31 May 2026
FDA grants breakthrough therapy designation for calderasib (MK-1084), an investigational KRAS G12C inhibitor, for certain patients with newly diagnosed metastatic KRAS G12C mutant non-small cell lung cancer
29 May 2026 - First breakthrough therapy designation for calderasib, supported by positive data from the Phase 1 KANDLELIT-001 trial. ...
Posted by Michael Wonder on 29 May 2026
Imfinzi approved in the US in first and only immunotherapy combination for patients with BCG naïve, high risk non-muscle-invasive bladder cancer
28 May 2026 - Based on POTOMAC Phase 3 trial results which showed a 32% reduction in the risk of ...
Posted by Michael Wonder on 28 May 2026
Cogent Biosciences announces FDA acceptance of new drug application with priority review for bezuclastinib in combination with sunitinib for patients with GIST
28 May 2026 - New drug acceptance acceptance with priority review builds upon previous assignment of breakthrough therapy designation and real-time ...
Posted by Michael Wonder on 28 May 2026
FDA approves durvalumab in combination with Bacillus Calmette-Guerin for high-risk non-muscle invasive bladder cancer
28 May 2026 - Today, the FDA approved durvalumab (Imfinzi, AstraZeneca) in combination with Bacillus Calmette-Guerin (BCG) for the treatment ...
Posted by Michael Wonder on 28 May 2026
US FDA approves Decnupaz (pivekimab sunirine-pvzy) for treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm, an ultra rare and aggressive blood cancer with limited treatment options
27 May 2026 - AbbVie today announced that the US FDA has approved Decnupaz (pivekimab sunirine-pvzy) for the treatment of ...
Posted by Michael Wonder on 28 May 2026
Solu Therapeutics granted FDA fast track designation for STX-0712 for treatment of chronic myelomonocytic leukaemia
27 May 2026 - Solu Therapeutics today announced that the US FDA has granted fast track designation to STX-0712, the company's ...
Posted by Michael Wonder on 27 May 2026
FDA approves pivekimab sunirine-pvzy for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare hematologic malignancy
27 May 2026 - Today, the FDA approved pivekimab sunirine-pvzy (Decnupaz, AbbVie), a CD123-directed antibody and alkylating agent conjugate, for ...
Posted by Michael Wonder on 22 May 2026
Datroway approved in the US as first TROP2 directed antibody drug conjugate for first-line treatment of patients with metastatic triple negative breast cancer who are not PD-1/PD-L1 inhibitor candidates
22 May 2026 - Daiichi Sankyo and AstraZeneca’s Datroway (datopotamab deruxtecan-dlnk) has been approved in the US for the treatment ...
Posted by Michael Wonder on 22 May 2026
Datroway approved in the US as first TROP2-directed antibody drug conjugate for 1st-line treatment of patients with metastatic triple-negative breast cancer who are not PD-1/PD-L1 inhibitor candidates
22 May 2026 - AstraZeneca and Daiichi Sankyo’s Datroway is the only TROP2-directed antibody drug conjugate to prolong overall survival in ...
Posted by Michael Wonder on 22 May 2026
FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic triple negative breast cancer
22 May 2026 - Today, the FDA approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo) for adult patients with unresectable or metastatic ...