Federal Register notice: FDA withdraws approval of an Air Products and Chemicals NDA and new animal drug application for medical gas helium because th...
FDA publishes a guidance to assist in the design and analysis of studies assessing the influence of impaired renal function on an investigational drug...
FDA grants Takeda Pharmaceutical accelerated approval for Iclusig (ponatinib) for use with chemotherapy in adult patients with newly diagnosed Philade...
FDA accepts for review a Citius Pharmaceuticals BLA resubmission for Lymphir (denileukin diftitox), an interleukin-2-based immunotherapy for treating ...
A bipartisan group of nine senators asks the Defense Department for an update on its efforts to secure the military pharmaceutical supply chain.
Two stakeholders make suggestions to revise an FDA draft guidance on its new drug advanced manufacturing technology designation program.
FDA sends Warning Letters to Jiangsu Shenli Medical Production Co. Ltd, a China-based plastic syringe manufacturer, and Medline Industries and Sol-Mil...
FDA approves an Optinose NDA for Xhance (fluticasone propionate) nasal spray for treating chronic rhinosinusitis without nasal polyps in patients 18 y...
