FDA approves Genentechs Itovebi to be used with two other drugs to treat some breast cancers identified through a diagnostic test.
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...
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...
