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ASCO’s Call-to Action: Advancing Patient-focused and Decentralized Clinical Trials

Required adaptations to clinical trial design and execution, implemented during the COVID-19 pandemic, have put a new focus on the development of patient-focused, decentralized...

FDA Clears IND Application for a Phase 1/2 Study of OBI-992...

The U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for OBI-992 (also known as BSI-992), to conduct a...

Enfortumab vedotin + Pembrolizumab Approved by US FDA as the First...

Enfortumab vedotin + Pembrolizumab Approved by US FDA as the First and Only ADC + PD-1 Combination to Treat Advanced Bladder Cancer

FDA Grants Fast Track Designation for ARX517 in Metastatic Castration-Resistant Prostate...

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ARX517, a proprietary anti-PSMA antibody-drug conjugate (ADC) investigational being therapy developed by Ambrx for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) upon progression on an androgen receptor pathway inhibitor.

Project Optimus: How to Prepare for Success

For some time now, cancer drug developers have known “Project Optimus” and new dose optimization expectations are coming their way from the Food and...

ImmunoGen Submits Biologics License Application for Mirvetuximab Soravtansine in Ovarian Cancer

Immunogen has submitted a Biologics License Application (BLA) under the accelerated approval pathway to the US Food and Drug Administration (FDA) for mirvetuximab soravtansine...

CHMP Adopts Positive Opinion for Belantamab Mafodotin, Recommending Approval for the...

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of...

Advisory Committee Votes in Favor of Positive Benefit/Risk Profile for Belantamab...

The U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) has voted 12-0 in favor of positive benefit/risk profile for belantamab mafodotin...

FDA Lifts Partial Clinical Hold on Pivotal Phase II Clinical Trial...

Earlier this week the U.S. Food and Drug Administration (FDA) lifted a partial clinical hold on the pivotal Phase II clinical study of camidanlumab...

OBI-999, a Novel First-in-class ADC, Granted FDA Orphan Drug Designation for...

OBI-999, a novel antibody-drug conjugate or ADC being developed by OBI Pharma, a Taiwan based biopharmaceutical company, has been granted orphan drug designation for...

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