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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...
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Environmental Risk Assessment and New Drug Development

1.0 Abstract In our globalized world, human pharmaceutical residues and traces of other (chemical) down-the-drain contaminants have become an environmental concern. Following the detection of...

Novasep finalizes €11M bioconjugation facility in Le Mans, France

Thius week, following the World ADC Summit in Berlin, Germany, Novasep, a leading supplier of services and technologies for the life sciences industry, announced...
Drugs & Durg Hunters

Drugs and Drug Hunters

All products of the creative process are a reflection of the individual makeup of the inventors.  A painting by Mark Rothko looks like a...

Evolving CMC Analytical Techniques for Biopharmaceuticals

1.0 Abstract During the (early) preclinical drug development process as well as manufacturing of biopharmaceutical (protein) products, analysis and characterization are crucial in gaining a...

Modernization of Regulatory Protocol and Initiatives for Advancing Precision Medicine

Over the last decade, Targeted Therapies, Personalized and Precision Medicine have become part of our vocabulary, representing a new way of thinking in how...

Can the President Still Cure Cancer?

Forty- five years ago, in a room filled with congressional members from both sides of the isle, distinguished guests, and a contingent of press,...

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