Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 20 May 2026
ImmunityBio announces FDA acceptance of supplemental BLA for Anktiva plus BCG in BCG-unresponsive non-muscle invasive bladder cancer with papillary disease
19 May 2026 - ImmunityBio today announced that the US FDA has accepted for review the supplemental biologics license application for ...
Posted by Michael Wonder on 18 May 2026
US FDA grants priority review to supplemental new drug application for Hyrnuo (sevabertinib) under investigation as a first-line treatment of HER2 mutated non-small cell lung cancer
18 May 2026 - Regulatory submission for first-line use of Hyrnuo is based on results from the on-going Phase I/II SOHO-01 ...
Posted by Michael Wonder on 15 May 2026
Alloplex Biotherapeutics receives FDA fast track designation for Suplexa in colorectal cancer indication
13 May 2026 - Alloplex Biotherapeutics announces that the US FDA has granted fast track designation to Suplexa for the treatment ...
Posted by Michael Wonder on 15 May 2026
FDA approves two separate indications for fam-trastuzumab deruxtecan-nxki in HER2-positive early-stage breast cancer
15 May 2026 - Today, the FDA approved fam-trastuzumab deruxtecan-nxki (T-DXd, Enhertu, Daiichi Sankyo) for two separate indications in adults ...
Posted by Michael Wonder on 15 May 2026
FDA approves atezolizumab for adjuvant treatment of muscle invasive bladder cancer in patients with molecular residual disease
15 May 2026 - Today, the FDA approved atezolizumab (Tecentriq, Genentech) and atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech) as adjuvant ...
Posted by Michael Wonder on 12 May 2026
Emiltatug ledadotin granted breakthrough therapy designation by the US FDA for adenoid cystic carcinoma
12 May 2026 - Servier today announced that the US FDA has granted breakthrough therapy designation to emiltatug ledadotin, an investigational ...
Posted by Michael Wonder on 11 May 2026
Zai Lab receives US FDA fast track designation for zocilurtatug pelitecan (Zoci), a DLL3 targeting ADC, for treatment of extrapulmonary neuroendocrine carcinomas
11 May 2026 - Zai Lab today announced the US FDA has granted fast track designation to zocilurtatug pelitecan (zoci, formerly ...
Posted by Michael Wonder on 08 May 2026
Nuvation Bio announces FDA acceptance of supplemental new drug application for Ibtrozi (taletrectinib) with updated duration of response in advanced ROS1 positive non-small-cell lung cancer
6 May 2026 - Application includes updated TRUST-I TKI naïve median duration of response and median progression-free survival of more than ...
Posted by Michael Wonder on 08 May 2026
Rznomics announces US FDA regenerative medicine advanced therapy designation granted to RZ-001 for hepatocellular carcinoma
8 May 2026 - RMAT designation based on promising Phase 1b/2a clinical data, including safety profile and preliminary response rates, ...