CHICAGO--(BUSINESS WIRE)--Emalex Biosciences today announced that the U.S. Food and Drug Administration has authorized the company’s Expanded Access Program (EAP) for ecopipam, an investigational ...
The U.S. Food and Drug Administration (FDA) has issued updated guidance on Expanded Access to Investigational Drugs for Treatment Use, clarifying how drug developers, physicians, and patients can ...
Health system pharmacists and clinicians are monitoring a wave of drug approvals expected throughout 2026, including first-in-class therapies and expanded uses of existing drugs with implications for ...
A rare but severe stem cell transplant complication that often becomes fatal now has its first FDA-approved treatment, a therapy developed by biotechnology company Omeros. The Christmas Eve regulatory ...
NEW YORK--(BUSINESS WIRE)-- Nuvation Bio Inc. (NUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today announced it has initiated an Expanded Access ...