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...
Federal Register notice: FDA submits to OMB a revised information collection entitled Guidance for Industry: Expedited Programs for Serious Conditions...
FDA denies without comment a fourth United Therapeutics petition seeking specific requirements for approval of any ANDA referencing its Tyvaso.
FDA generic drug researchers say modeling can shorten development time for generic drug-device combination drugs.