Drug Approval | July 11, 2025
FDA accepts new drug application for Merck’s Doravirine/Islatravir
The FDA set a target action date of April 28, 2026, under the Prescription Drug User Fee Act
The FDA set a target action date of April 28, 2026, under the Prescription Drug User Fee Act
Xtandi is approved in over 80 countries, including the U.S., EU, and Japan
The first project will focus on developing an AI-based platform for the sterically guided design of bispecific antibodies
India’s fertility rate has dropped to 1.9, below the replacement level of 2.1
The Stryker Mako Robotic System uses artificial intelligence to improve surgical accuracy with real-time guidance, personalized planning, and precise execution
Addresses brain metastases harboring BRCA1/2 and/or HRR alterations—an area of high unmet need
The audit has been concluded with no major observations
Approval based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death for the Imfinzi regimen vs. neoadjuvant chemotherapy alone
The study showed that sClever-1 is released by macrophages and blood vessel cells and binds to activated T cells
ARGX-119 is the sixth molecule developed through our Immunology Innovation Program to show proof-of-concept
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