Arrow International recalls its Arrow AutoCAT 2 Intra-Aortic Balloon Pump and AC3 Optimus Intra-Aortic Balloon Pump Series because both devices have a...
Public Citizen writes to FDA commissioner Stephen Hahn and three others seeking a declaration that challenge studies will not be authorized as part of...
Federal Register notice: FDA withdraws approval of Tevas NDA for Zecuity (sumatriptan iontophoretic transdermal system) after the company requested it...
FDA places a clinical hold on a Cellectis multiple myeloma trial (MELANI-01 study) after a study patient died.
A House appropriations subcommittee approves by voice vote a bill that includes an additional $41 million for FDA in fiscal year 2021.
FDA publishes a list of the latest REMS updates for five drugs.
FDA releases its latest batch of Warning Letters that includes Greiner Bio-One, Luminex Corp. and Vega Life Sciences.
Federal Register notice: FDA sends to OMB an information collection extension for Radioactive Drug Research Committees.