ProDx Health – 720762 – 02/10/2026

Delivery Method: Via UPS and EMAIL Reference #: CBER 26-720762 Product: Biologics Recipient: Recipient Name Andreas Kogelnik, MD, PhD Recipient Title Founder & Chief Executive Officer ProDx Health 1190 O’Brien DrMenlo Park, CA 94025United States...

Louisville Reproductive Center – 722350

Delivery Method: VIA UPS and Electronic Mail Reference #: CBER 26-722350 Product: Biologics Recipient: Recipient Name Dr. Miriam S. Krause Recipient Title Medical Director Louisville Reproductive Center 4123 Dutchmans Lane, Suite 416Louisville, KY 40207-4733United...

FDA approves pembrolizumab with paclitaxe

On February 10, 2026, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) as well as pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) in combination with paclitaxel, with or without bevacizumab, for adult patients with...

Regulatory Science at CDER

Regulatory science at FDA is the science of developing new tools, standards, and approaches to assess the safety and performance of the products the Agency regulates.CDER’s regulatory science activities aim to speed the development of new drugs while ensuring...
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