FDA approves Astex Inqovi to treat adults with myelodysplastic syndromes.
FDA warns Indias Vega Life Sciences about CGMP deviations in the production of active pharmaceutical ingredients.
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.