FDA approves an IDE for Iota Biosciences to conduct a feasibility study of its investigational implantable device designed to deliver electrical stimu...
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...
Some 21 House Democrats and Republicans ask FDA to take more steps to prevent drug shortages as the Drug Supply Chain Security Act hits its 11/27 impl...
Neuvivo files an NDA for NP001 (sodium chlorite infusion) for treating amyotrophic lateral sclerosis (also known as Lou Gehrigs disease).
An FDA Science Advisory Board subcommittee calls on the agency to create a centralized office to coordinate work on New Alternative Methods.
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...
