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The approval was based on data from the pivotal phase 3 EMPOWUR study.
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Cross-sectional data from the National Health and Nutrition Examination Survey from 1988 to 1994 and 1999 to 2016 were used for this analysis.
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The FDA has approved Saxenda® (liraglutide; Novo Nordisk) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in patients aged 12 years and older with body weight >60kg and an initial BMI corresponding to ≥30kg/m2 for adults (obese).
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The approval was based on data from the phase 1/2 ARROW trial which evaluated the efficacy and safety of Gavreto in patients with RET-mutant MTC.
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Approval was based on results from two phase 2 single-arm, open-label trials that demonstrated overall response rate and duration of response.
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Lumasiran is an investigational ribonucleic acid interference therapeutic that inhibits hepatic production of oxalate by targeting hydroxyacid oxidase 1.
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Zokinvy works by preventing farnesylation and subsequent accumulation of progerin and progerin-like proteins in the inner nuclear membrane.
Drugs in the Pipeline
Results from the final analysis showed that cabotegravir was 66% more effective than FTC/TDF in preventing HIV acquisition.
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This action was in response to an executive order issued on August 6, 2020 aimed at protecting the public against outbreaks of emerging diseases and chemical, biological, radiological, and nuclear threats.
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Difelikefalin, an investigational intravenous drug, improved moderate to severe itching compared with placebo in patients on hemodialysis, according to phase 3 trial results.