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Navigating FDA’s Proposed Guidance on AI and Non-Animal Models: Safeguarding Innovation in Drug Development

In April 2025, the U.S. Food and Drug Administration (FDA) released a landmark guidance titled “Roadmap to Reducing Animal Testing in Preclinical Safety Studies,” outlining its commitment to advancing New Approach...more

AI Drug Development: FDA Releases Draft Guidance

On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products...more

Antibody Drug Conjugates Keep Growing: What You Need to Know

What Are ADCs and Why Are They Growing? Over the past few years economic headwinds have resulted in fewer deals, with companies and private equity firms alike reassessing where to spend money. But one portion of the...more

Cancer Drugs: Strategies For Patenting Antibody-Drug Conjugate Inventions

Antibody-drug conjugate (ADC) is a promising class of cancer treatments with accelerating U.S. Food and Drug Administration (FDA) approval and rapidly growing market size as discussed in previous articles in this series. This...more

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