At the beginning of July 2026, the U.S. Food and Drug Administration approved the first gene therapy for young children with ...
Navigating the FDA approval process ranks among the most complex challenges facing manufacturers and distributors of regulated products today. Whether a ...
New legislation introduced by a bipartisan group of US senators would make it more difficult for new and generic opioid drugs to obtain the approval of the US Food and Drug Administration (FDA). The ...
It takes about 14 years to get a new drug approved by the Food and Drug Administration. That leaves drug companies about six years of exclusive sales until their 20-year patent expires, and they ...