The Medical Information Working Group says FDA should incorporate principles from five recent Supreme Court free speech decisions into its considerati...
Federal Register notice: FDA announces a 12/17 Oncologic Drugs Advisory Committee meeting that with discuss an AstraZeneca supplemental NDA for Lynpar...
The Justice Department says Rising Pharmaceuticals will pay over $3 million to resolve price fixing charges and will cooperate with an ongoing investi...
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.