January 24th 2025
This class 2 recall of almost 3000 First Aid Beauty brand face moisturizers resulted from deviation from Current Good Manufacturing Practice regulations.
January 23rd 2025
The approval of Amneal Pharmaceuticals’ generic version of rifaximin 550 mg oral tablets is tentative due to the product’s involvement in litigation.
January 21st 2025
The Breakthrough Therapy designation comes just months after positive phase 2 data for brelovitug were presented at AASLD The Liver Meeting in 2024.
The FDA approved esketamine (SPRAVATO) nasal spray as the first monotherapy for adults with TRD, showing rapid efficacy at 4 weeks.
January 20th 2025
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 18, 2025.