Attorneys at Hogan Lovells say (XXX DELETE s XXX)that a final guidance on electronic records and systems used in clinical trials includes a broader sc...
Teva Pharmaceuticals agrees to pay $450 million to resolve two civil cases that allege the company violated the Anti-Kickback Statute and the False Cl...
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.
