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clinical trial

Vor Biopharma Announces Collaboration with Janssen to Develop Engineered Hematopoietic Stem Cell Transplants Combined with a Bi-Specific Antibody Therapy for Acute Myeloid Leukemia (AML)

[Vor Biopharma] Vor Biopharma, a cell therapy company pioneering engineered hematopoietic stem cell therapies combined with targeted therapies for the treatment of cancer, announced the formation of a collaboration with Janssen Biotech, Inc.

First Ever Drug Treatment for Aggressive Pediatric Bone Disease Nears FDA Approval

[Children’s Hospital of Philadelphia] The FDA has accepted a new drug application for palovarotene, a drug identified by researchers at Children’s Hospital of Philadelphia to treat fibrodysplasia ossificans progressiva.

SAB Biotherapeutics Doses First Participant in Phase IIa Trial of SAB-176 for the Treatment of Influenza

[SAB Biotherapeutics] SAB Biotherapeutics announced that the first participant has been dosed in its Phase IIa clinical trial evaluating the safety and efficacy of SAB-176 in a human challenge study.

Knight Therapeutics Announces Health Canada Approval for NERLYNX® (Neratinib) to Treat HER2-Positive Metastatic Breast Cancer

[Knight Therapeutics, Inc.] Knight Therapeutics, Inc. announced that Health Canada has approved NERLYNX® in combination with capecitabine for the treatment of adult patients with metastatic HER2-overexpressed/amplified breast cancer, who have received two or more prior anti-HER2-based regimens in the metastatic setting. The approval was based on results of the global Phase III NALA trial.

TRIO Completes Enrollment for Phase II Giredestrant Early Breast Cancer Trial Ahead of Schedule

[Translational Research in Oncology] Translational Research in Oncology (TRIO) announced enrollment completion in coopERA Breast Cancer, a Phase II clinical trial of giredestrant, an oral selective estrogen receptor degrader that showed encouraging tumour activity both alone and in combination with palbociclib in estrogen-receptor positive metastatic breast cancer patients.

Direct Biologics Granted FDA Approval of Third IND Application for the Use of ExoFlo in Mild-to-Moderate COVID-19 Infusion Therapy

[Direct Biologics LLC] Direct Biologics LLC announced that the FDA has approved the application for a Phase I/II trial under an Investigational New Drug (IND) protocol for the use of ExoFlo™ in the treatment of mild-to-moderate COVID-19. ExoFlo™ is an extracellular vesicle product isolated from human bone marrow MSCs.

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