Richard Pazdur, the new director of the Center for Drug Evaluation and Research, raised concerns amid the rollout of several ...

Richard Pazdur, who assumed his new role this month, has warned that new Trump administration initiatives could be illegal and pose a risk to public health.

The integration of Artificial Intelligence (AI) in various sectors has been nothing short of transformative, and now, it’s poised to revolutionize the pharmaceutical industry. The U.S. Food and Drug ...

Companies should really sit down and say, could I meet these points?” Hogan Lovells partner Lynn Mehler said. “How do I ...

Drugs approved by the FDA’s expanding program to expedite reviews for products in line with the Trump administration’s agenda ...

Kaiser Health News interviewed Robert Califf, MD, former FDA commissioner, concerning his thoughts on the drug approval process and the current presidential administration’s outlook on quickening the ...

The "The FDA (Food and Drug Administration) Drug Approval Process Training Course (Feb 23rd - Feb 24th, 2026)" training has been added to ResearchAndMarkets.com's offering. The US is the largest ...

The FDA has granted priority review status for pegcetacoplan (Empaveli) to treat two rare kidney diseases that can lead to kidney failure. Up until now, there hadn’t been any drugs approved ...

DENVER — A "huge" number of life-years is being unnecessarily lost because of delays in cancer drug approvals, according to research presented here at the 16th World Conference on Lung Cancer. Every ...

Patent reforms could address a problem that’s been driving rising prescription drug costs and create a more competitive ...

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...

Biologics represented 5% of the drugs prescribed in the U.S. in 2024, but they accounted for more than half of the country’s ...