Results from a study evaluating the safety and efficacy of suvorexant (Merck) for the treatment of insomnia in patients with mild to moderate Alzheimer disease dementia were presented at the 2019 American Academy of Neurology Annual Meeting. The phase 3 placebo-controlled trial included 277 patients who were randomized to receive either suvorexant 10mg (which could…
The NDA for Talicia for the treatment of Helicobacter pylori (H. pylori) infection has been submitted to the FDA by RedHill Biopharma.
The FDA has approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) for the treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.
The Food and Drug Administration (FDA) has approved Kadcyla (ado-trastuzumab emtansine; Genentech) for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. The approval was supported by data from the phase 3 KATHERINE study which evaluated the safety and efficacy of Kadcyla vs…
The FDA has expanded the indication for Tibsovo to include treatment of newly diagnosed acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.
The FDA has issued a second complete response letter to Acacia Pharma regarding the New Drug Application for Barhemsys (amisulpride injection).
Results from a phase 3 trial evaluating Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol; GlaxoSmithKline) in patients with uncontrolled asthma showed that the single inhaler triple therapy provided a significant improvement in lung function when compared with Breo Ellipta.
Par is recalling 1 lot of Mycophenolate Mofetil for Injection (lot# AD812; expiration date: 9/2020) following the discovery of a glass fragment within a reconstituted vial.
The Food and Drug Administration (FDA) has approved Dengvaxia (dengue tetravalent vaccine, live; Sanofi) for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4.
The FDA has approved Mavyret (glecaprevir and pibrentasvir; AbbVie) for the treatment of all 6 genotypes of hepatitis C virus in children 12 to 17 years old or weighing at least 45kg.
