Articles

New guidance looks to streamline safety assessment process.

Cutting to the Chase on European "Safety Assessing Member States" in Clinical Trials

Dr. Harish Dave, CEO of Singapore-based AUM Biosciences, discusses evolving strategies for Asian biopharmaceutical enterprises.

Asian Biotech Clinical Trial Demand Moves to the West

New therapies were approved at a steady pace in 2021.

FDA Keeps New Drugs Coming

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.

The European Union is reaching out for independent experts to help advise on its health development programs in needy areas of regulatory science.

Helping Hands for Europe and Health?

The Innovative Health Initiative is expected to launch its first call for proposals early this year.

European Drug Research Takes on A Wider Perspective

Pfizer’s Paxlovid has gained emergency use authorization at a time when the U.S. is being devastated by the spreading Omicron variant.

Here Come the COVID Treatment Options

Object lessons in implementing next-generation sequencing in cancer diagnosis in Europe.

Belgium Develops Approach to Overcome Challenges of Sequencing

Three key insights about clinical trial advancements made possible by the advent of metrics

A Critical Piece of the Research Puzzle: How Metrics Have Transformed Clinical Trials

FDA has become embroiled in the debate over access to “chemical” or “medication” abortions through the prescribing and distribution of the abortifacient, mifepristone.

FDA Caught In Abortion Battles

The Biden administration’s choice to lead FDA successfully navigated a Senate confirmation hearing on Dec. 14, setting the stage for full Senate approval early next year.

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