FDA Broadens Access to Over-the-Counter Naloxone Nasal Spray for Opioid Overdose
The U.S. Food and Drug Administration (FDA) today approved another over-the-counter (OTC) intranasal naloxone product, Rextovy, a 4 milligram (mg)…
Regulatory Approvals
Merck (MRK) Wins FDA Approval For First Once Daily Oral PCSK9 Drug
Merck (MRK) Wins FDA Approval For First Once Daily Oral PCSK9 Drug simplywall.st
FDA Approves First Single-Dose Generic Treatment for Influenza
The U.S. Food and Drug Administration today approved the first generic of Xofluza (baloxavir marboxil) tablets, the first single-dose treatment…
FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol
The U.S. Food and Drug Administration approved Lipfendra (enlicitide), the first oral inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9),…
FDA Issues Emergency Use Authorization for Drug for Short-Term Prevention of New World Screwworm in Horses
The FDA today issued an Emergency Use Authorization (EUA) for Ivermectin Liquid for Horses (ivermectin oral solution) for the short-term…