Biopharma bites: Full FDA approval for Fabhalta, plus Dimerix’s renal buy
Biopharma bites: Full FDA approval for Fabhalta, plus Dimerix's renal buy FirstWord PHARMA
Regulatory Approvals
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…
FDA Approves First Gene Therapy for Young Children with Sickle Cell Disease
The U.S. Food and Drug Administration today issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged 2 years…