Hepatic impairment

The phase 3 ADVANCE trial evaluating the investigational medicine Atogepant, an orally administered calcitonin gene-related peptide ( CGRP ) receptor...


The FDA ( U.S. Food and Drug Administration ) has approved Ofev ( Nintedanib ) capsules to slow the rate...


The U.S. Food and Drug Administration ( FDA ) has approved Cyramza ( Ramucirumab injection, 10 mg/mL solution ), as...


The European Commission has approved a label update for the use of once-daily Relvar Ellipta ( Fluticasone furoate / Vilanterol,...



The European Commission ( EC ) has granted marketing authorization for Plegridy ( Peginterferon beta-1a ) as a treatment for...


The treatment of drug sensitive strains of tuberculosis ( TB ) requires minimum duration of 6 months. However, for multiple...


Three published reports ( one Canadian case and two international cases ) have indicated a probable causal association between Quetiapine...


In the EU ( European Union ), Zydelig ( Idelalisib ) is indicated in combination with Rituximab ( MabThera )...


Domperidone ( Motilium ) is associated with a small increased risk of serious cardiac side effects. Its use is now...


Hetlioz, a melatonin receptor agonist, is indicated for the treatment of non-24-hour sleep-wake disorder ( Non-24 ).Important safety informationHetlioz may...


Cerdelga ( Eliglustat ), a novel glucosylceramide analog given orally, was designed to partially inhibit the enzyme glucosylceramide synthase, which...


Ruxolitinib ( Jakafi ) is an oral, selective inhibitor of Janus kinases 1 and 2 ( JAK1 and JAK2 )....


Elevations of liver enzymes occur in 1-10 patients out of every 100 treated with Lenalidomide ( Revlimid ) for multiple...


European Commission ( EU ) has granted marketing authorization for Aubagio ( Teriflunomide ) 14 mg, a once-daily, oral therapy...


The FDA ( Food and Drug Administration ) has approved updates to the full U.S. Prescribing Information ( PI )...


The results from two exploratory analyses assessing the risk of hypoglycemia with Linagliptin ( Tradjenta ) treatment in adults with...


The results from two phase III clinical studies that showed Linagliptin ( Tradjenta ) in Asian adults, as monotherapy and...


The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion recommending a change to...


Use of Nitrofurantoin for urinary tract infections is contraindicated in patients with less than 60 mL/min creatinine clearance. Healthcare professionals...