Attorney Michelle Yeary says a New York federal court finally ruled on a Sun Pharmaceutical motion to dismiss claims in a failure to warn suit five ye...
FDA releases the FDA-483 issued with eight observations from a Zimmer Biomet inspection.
FDA issues its congressionally mandated report on progress under the GAIN (Governing Antibiotic Incentives Now) law.
FDA issues a guidance on Microbiology Data for Systemic Antibacterial Drugs Development, Analysis, and Presentation.
FDA clears an Empatica 510(k) for Embrace, a smart watch that monitors for seizures known as grand mal or generalized tonic-clonic seizures.
Bristol-Myers Squibb says that its ongoing Phase 3 CheckMate-227 study met its co-primary endpoint of progression-free survival with the Opdivo (nivol...
FDA releases its latest batch of Warning Letters that includes Celltrion and Polaroisin International.
Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Amgens Blincyto (blinatumomab) is 2,850 da...