Keytruda (pembrolizumab): a deep-dive
What it is. Keytruda is Merck & Co.’s (MSD outside the US/Canada) humanized IgG4 monoclonal antibody that blocks PD-1, releasing an immune “brake” so T-cells can attack cancer. In the EU it’s authorized—alone and in combinations—across a very broad slate of tumors (NSCLC, melanoma, RCC, urothelial, HNSCC, MSI-H/dMMR cancers, gastric/GEJ, oesophageal, cervical, TNBC, biliary tract, […]
Deep brief — Formal Meetings Between FDA and Sponsors/Applicants of BsUFA Products
Guidance for Industry (CDER & CBER, July 2025) — what it says, why it matters, and exactly what regulatory, pharmacovigilance (PV), quality, clinical and commercial teams must do day-to-day. U.S. Food and Drug Administration Quick summary (the headline) This FDA guidance codifies how sponsors of biosimilar or interchangeable biologic products should request, prepare for, run, […]