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 releases the form FDA-483 with 12 observations from a 2023 inspection at Chinas Nanchang Anobri drug manufacturing facility.
Zyno Medical recalls (Class 1 device correction) various models of its Z-800 Infusion System due to a defect in the air in-line software.
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).
