Tempus AI Inc. and Stemline Therapeutics Inc. announced a new collaboration. The two companies will leverage Next—Tempus’ AI-enabled care pathway intelligence platform—to help clinicians determine when an ESR1 test may be appropriate.
DeepHealth and ConcertAI’s TeraRecon announced a strategic collaboration to integrate certain capabilities to advance imaging tools and the radiology workflow.
FDA granted priority review to Boehringer Ingelheim’s new drug application for BI 1810631 (zongertinib) for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer whose tumors have HER2 mutations and who have received prior systemic therapy.
FDA approved Adcetris (brentuximab vedotin) in combination with lenalidomide and a rituximab product for adult patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are ineligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or CAR T-cell therapy.
FDA approved Gomekli (mirdametinib), a kinase inhibitor from SpringWorks Therapeutics, for adult and pediatric patients two years of age and older with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection.
The European Commission granted marketing authorization for Removab (catumaxomab), making the drug the only approved drug therapy for malignant ascites for patients living with this debilitating condition across Europe.
Moffitt Cancer Center and 1ST Biotherapeutics are collaborating to accelerating innovative cancer research and clinical development.
FDA granted orphan drug designation to MB-105, March Biosciences’s first-in-class CD5-targeted CAR T-cell therapy, for the treatment of relapsed/refractory CD5-positive T-cell lymphoma.
The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approval of Opdivo (nivolumab) plus Yervoy (ipilimumab) from Bristol Myers Squibb for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma, based on results from the phase III CheckMate-9DW trial. The CHMP opinion will now be reviewed by the European Commission.
CHMP recommended approval of Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor T-cell therapy, for the treatment of adult patients with relapsed or refractory follicular lymphoma who have received two or more prior lines of systemic therapy.
