The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

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 ...

Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include novel drugs that offer new treatment options, as well as first generics and ...

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 ...

FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...

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 ...

Six weeks after a reduction in force (RIF) at the US Food and Drug Administration removed thousands of workers, signs are emerging about how the agency’s approach to drug approval may change. The 20% ...

Accelerated drug development and approval pathways, designed to expedite the delivery of essential medicines for patients with serious and rare diseases, have been successfully implemented in the ...

NEW YORK, Aug. 29, 2025 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today announced its approval of a subcutaneous formulation of Leqembi (lecanemab), branded as Leqembi Iqlik, for ...

This is read by an automated voice. Please report any issues or inconsistencies here. A rare-disease patient questions what drives research costs behind $41,000-per-month medication, even before FDA ...