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
Acquisition aligns with Merck’s science-led business development strategy and expands pipeline and portfolio of treatments for cardio-pulmonary diseases
Insights are drawn from over 30K+ people across 300+ cities including all metro and tier-1 cities
Additional data will be presented on a once-weekly oral combination of islatravir and ulonivirine (ISL/ULO) for HIV-1 treatment
The submission is based on data from the STEP UP and STEP UP T2D clinical trials
Lupin and Zentiva sign license and supply agreement for commercializing Certolizumab
Prof. Götz is Director of the Institute of Stem Cell Research at Helmholtz Center Munich and Chair of Physiological Genomics at Ludwig-Maximilians-Universität, Munich
The pharmaceuticals laboratory supports North Asia with formulation development, reverse engineering, troubleshooting, and analysis for various dosage forms
He has held senior leadership positions at Syngene International, Fujifilm Diosynth Biotechnologies, Thermo Fisher Scientific, Sartorius Stedim Biotech, and other leading organizations
Addresses brain metastases harboring BRCA1/2 and/or HRR alterations—an area of high unmet need
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