Posts Tagged: Biologics

FDA Roundup: June 2, 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 an update on…

FDA Roundup: May 30, 2023

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

FDA Roundup: May 26, 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 warning letters…

FDA Roundup: May 23, 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 and the Veterans…

FDA Approves First Topical Gene Therapy for Treatment of Wounds in Patients with Dystrophic Epidermolysis Bullosa

Today, the U.S. Food and Drug Administration approved Vyjuvek, a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy, for the treatment of wounds in patients…

FDA Roundup: May 19, 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 announced that the National…

FDA Roundup: May 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 updated its new Rumor…

FDA Roundup: May 12, 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 updated information on medical…

FDA Finalizes Move to Recommend Individual Risk Assessment to Determine Eligibility for Blood Donations

Today, the U.S. Food and Drug Administration finalized recommendations for assessing blood donor eligibility using a set of individual risk-based questions to reduce the risk…

FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine

Today, the U.S. Food and Drug Administration approved Arexvy, the first respiratory syncytial virus (RSV) vaccine approved for use in the United States. Arexvy is…