FDA approves a Procept BioRobotics IDE for a clinical trial comparing its Aquablation therapy to radical prostatectomy in men with prostate cancer.
FDA issues Zealand Pharma a complete response letter on its NDA for dasiglucagon and its use in preventing and treating hypoglycemia in pediatric pati...
FDA accepts a Bayer NDA for elinzanetant, a non-hormonal investigational compound for treating moderate-to-severe hot flashes associated with menopaus...
FDA grants exemptions to Drug Supply Chain Security Act eligible connected trading partners, pushing the implementation date for enhanced drug distrib...
GSK says trial data show its Arexvy protects through three complete RSV seasons.
FDA says six products manufactured at Baxters hurricane-damaged facility in North Carolina are now on the shortage list.
FDA warns the Louisiana State University institutional review board that it failed to follow legislation and regulations to protect human subjects.
FDA releases the form FDA-483 with 10 observations from an inspection at the Apitoria Pharma active pharmaceutical ingredient manufacturing facility i...
