Awarded to Taro Pharmaceuticals Industries, this generic approval is targeted to reduce the risk of major cardiovascular events in adult patients with coronary artery disease and the risk of major thrombotic vascular events in adult patients with peripheral artery disease, including patients who have recently undergone a lower extremity revascularization procedure.
A new clinical trial map is now accessible from the public website of the Clinical Trials Information System (CTIS). The map is designed to provide patients and healthcare professionals with easy access to comprehensive, real-time information about clinical trials conducted in their area, increasing access to clinical research in the European Union (EU).
The US Pharmacopeia (USP) has published its 2024-2025 Vulnerable Medicines List for the US, cataloguing “a data-based approach to identify risks and enable interventions to increase reliability of supply’.
A paper published by the Drug Safety Research Unit (DSRU) in the British Journal for Clinical Pharmacology, has asserted the need for ongoing assessment of the safety and effectiveness of the Alzheimer’s drug lecanemab in the real-world clinical setting.
U.S. Food and Drug Administration approved as the first interchangeable biosimilar to Xolair (omalizumab).
EMA has recommended granting a marketing authorisation in the European Union (EU) for Vyjuvek (beremagene geperpavec) to treat wounds in patients of all ages with dystrophic epidermolysis bullosa (DEB).
EMA’s human medicines committee (CHMP) has recommended extending the therapeutic indication of two medicines, Kaftrio (ivacaftor / tezacaftor / elexacaftor) and Kalydeco (ivacaftor) for the treatment of cystic fibrosis, to include their use in combination for patients aged two years and older who have at least one non-class I mutation in the cystic fibrosis transmembrane …
Combination of cystic fibrosis medicines to treat patients with rare mutations Read More »
DA informed sponsors of testosterone products about new labeling changes following the agency’s review of the findings from the Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) clinical trial and the results from required postmarket ambulatory blood pressure (ABPM) studies.
