Archive for July, 2023

FDA Approves Second Over-the-Counter Naloxone Nasal Spray Product

Today, the U.S. Food and Drug Administration approved RiVive, 3 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription use for the emergency treatment…

FDA Roundup: July 28, 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 approved Ervebo, a…

FDA Takes Steps to Facilitate Innovation for Devices Intended to Treat Opioid Use Disorder

Today, the U.S. Food and Drug Administration announced new steps to help facilitate innovation in devices intended to treat opioid use disorder (OUD). The draft…

FDA Roundup: July 25, 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 reopened the comment…

FDA Roundup: July 21, 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 Center for Tobacco Products…

FDA Roundup: July 18, 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 announced the findings…

FDA Approves New Drug to Prevent RSV in Babies and Toddlers

Today, the U.S. Food and Drug Administration approved Beyfortus (nirsevimab-alip) for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and…

FDA Roundup: July 14, 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 re-issued two temporary…

FDA Approves First Nonprescription Daily Oral Contraceptive

Today, the U.S. Food and Drug Administration approved Opill (norgestrel) tablet for nonprescription use to prevent pregnancy— the first daily oral contraceptive approved for use…

FDA Roundup: July 11, 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’s Center for Veterinary Medicine…