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
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
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
Masitinib is targeted at patients who are no longer responding to hormone-sensitive prostate cancer treatments
These medicines are essential in preventing RhD immunisation during pregnancy
Anti-cancer patent now validated in Spain, the UK, and as a Unitary Patent covering multiple EU member states
Vevzuo is authorized for the prevention of skeletal related events in adults with advanced malignancies involving bone
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