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FDA publishes a guidance to assist in the design and analysis of studies assessing the influence of impaired renal function on an ...[ Price : $8.95]
FDA grants Takeda Pharmaceutical accelerated approval for Iclusig (ponatinib) for use with chemotherapy in adult patients with new...[ Price : $8.95]
FDA accepts for review a Citius Pharmaceuticals BLA resubmission for Lymphir (denileukin diftitox), an interleukin-2-based immunot...[ Price : $8.95]
A bipartisan group of nine senators asks the Defense Department for an update on its efforts to secure the military pharmaceutical...[ Price : $8.95]
Two stakeholders make suggestions to revise an FDA draft guidance on its new drug advanced manufacturing technology designation pr...[ Price : $8.95]
FDA sends Warning Letters to Jiangsu Shenli Medical Production Co. Ltd, a China-based plastic syringe manufacturer, and Medline In...[ Price : $8.95]
FDA approves an Optinose NDA for Xhance (fluticasone propionate) nasal spray for treating chronic rhinosinusitis without nasal pol...[ Price : $8.95]
FDA issues a Form 483 after it finishes a pre-license inspection of Abeonas Cleveland, OH manufacturing facility concerning the co...