Tag: FDA
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...
ImmunoGen and FDA Discuss Ongoing Development for Mirvetuximab Soravtansine
The United States Food and Drug Administration (FDA) has recommended that ImmunoGen conducts a new Phase III randomized trial to evaluate the safety and...
U.S. Food and Drug Administration Rejects Sacituzumab Govitecan
The U.S. Food and Drug Administration (FDA) has rejected sacituzumab govitecan also known as IMMU-132, a novel, investigational, antibody-drug conjugate or ADC consisting of...
A New Generation of Precisely Engineered CD74-Targeting ADCs Receive Orphan Drug...
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for STRO-001 for the treatment of multiple myeloma (MM).
In the United States,...
U.S. FDA Lifts Partial Clinical Hold for Mersana’s XMT-1522
The United States Food and Drug Administration (FDA) has lifted the partial clinical hold on the Phase I study of XMT-1522, a Dolaflexin® Antibody-drug...
