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...
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.
