FDA has accepted the filing of Telix Pharmaceuticals Limited’s New Drug Application for TLX007-CDx, a new and proprietary cold kit for the preparation of PSMA-PET imaging for prostate cancer.Â
FDA cleared the investigational new drug application for ZW191, a novel folate receptor-α targeted topoisomerase I inhibitor antibody-drug conjugate sponsored by Zymeworks.
The European Medicines Agency validated Bristol Myers Squibb’s Type II variation application for Opdivo (nivolumab) plus Yervoy (ipilimumab) as a potential first-line treatment option for adult patients with unresectable or advanced hepatocellular carcinoma who have not received prior systemic therapy.Â
The European Medicines Agency has accepted the marketing authorization application for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) or pomalidomide plus dexamethasone (PomDex) as a treatment for relapsed or refractory multiple myeloma.Â
FDA granted Fast Track designation for 225Ac-FL-020, a radiopharmaceutical which targets prostate-specific membrane antigen for the treatment of metastatic castration-resistant prostate cancer.
Boehringer Ingelheim and OSE Immunotherapeutics SA, a clinical-stage biotech company, announced that Boehringer will be progressing their first-in-class SIRPα immuno-oncology program into the next phase in clinical development.
The Wistar Institute is collaborating with Accelerated Biosciences Corp. to create a platform based on human trophoblast stem cells to explore new immunotherapies that use Accelerated Bio’s proprietary technology. This collaboration could generate various types of immune cells from hTSCs, changing the field of allogeneic immunotherapies.
FDA grants Fast Track designation to Syncromune Inc. for drug-device combo for solid tumors in mCRPC
FDA granted Fast Track designation to Syncromune Inc., a clinical-stage biopharmaceutical company, for SYNC-T SV-102 therapy, Syncromune’s lead candidate for the treatment of patients with metastatic castrate-resistant prostate cancer.
The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending the granting of conditional marketing authorization of Tepkinly (epcoritamab), a T-cell engaging bispecific antibody administered subcutaneously, as a monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending conditional marketing authorization of odronextamab to treat adults with relapsed/refractory follicular lymphoma or R/R diffuse large B-cell lymphoma, after two or more lines of systemic therapy.
