Posts Tagged: Biologics

FDA Roundup: June 30, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Thursday, the FDA’s Center for Tobacco…

FDA Roundup: June 27, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA published new frequently asked…

FDA Roundup: June 23, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Thursday, the FDA issued an updated…

FDA Approves First Gene Therapy for Treatment of Certain Patients with Duchenne Muscular Dystrophy

Today, the U.S. Food and Drug Administration approved Elevidys, the first gene therapy for the treatment of pediatric patients 4 through 5 years of age…

FDA Roundup: June 20, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA released its report on…

FDA Roundup: June 16, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA posted information on its…

FDA Roundup: June 13, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA published the FDA Voices:…

FDA Roundup: June 9, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA provided information to health…

FDA Announces Additional Steps to Modernize Clinical Trials

Today, the U.S. Food and Drug Administration is announcing the availability of a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at…

FDA Roundup: June 6, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Monday, the FDA issued a Letter…