Soleno Shares Soar Premarket on FDA Approval of Vykat XR
Soleno on Wednesday said the FDA approved its Vykat XR extended-release tablets for the treatment of hyperphagia, a chronic and life-threatening feeling of intense, persistent hunger, in people ages 4 ...
FDA approves first new UTI drug in decades
The Food and Drug Administration (FDA) has approved a new drug for treating urinary tract infections, the first such drug ...
US FDA approves first treatment for rare genetic disorder Prader-Willi syndrome
The U.S. Food and Drug Administration on Wednesday approved Soleno Therapeutics' drug to treat a rare genetic disorder, ...
Soleno Gets FDA Approval for Hyperphagia Drug
Soleno Therapeutics gained approval from the Food and Drug Administration for its hyperphagia drug. The biopharmaceutical company focused on treating patients with rare diseases said Wednesday it got ...
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Dexcom’s FDA warning letter reveals unauthorized changes to sensors
Dexcom made a significant design change to a component used in its sensors and did not adequately validate the change, ...