FDA approves a Genentech supplemental BLA for Tecentriq (atezolizumab) in combination with chemotherapy for the initial treatment of certain adults wi...
The White House Council of Economic Advisors cautions that House Democrats drug price bill will keep innovative new drugs off the market.
FDA grants RightEye a breakthrough device designation for the RightEye Vision System and its use in diagnosing Parkinsons Disease.
Aquestive Therapeutics completes a rolling NDA submission for Libervant (diazepam) Buccal Film for managing seizure clusters.
AdvaMed urges FDA to be transparent and flexible in developing plans for regulatory submissions in electronic format.
FDA releases its latest batch of Warning Letters that includes one medical product company American Contract Systems.
The House Energy and Commerce Oversight and Investigations Subcommittee plans a 12/10 hearing to question FDA on its foreign drug inspection program a...
FDA releases an FDA-483 with three observations issued following an inspection at AnazaoHealth.