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.
FDA warns Luminex Corp. about QS and MDR violations in its production of multiplexing systems.
Federal Register notice: FDA determines that Mylans Zovirax (acyclovir) oral capsule, 200 mg, was not withdrawn from sale for reasons of safety or eff...