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FDA grants Genmab and GlaxoSmithKline a breakthrough therapy designation for Arzerra (ofatumumab) in combination with chlorambucil...[ Price : $8.95]
Hospira recalls one lot of 0.25% bupivacaine HCl Injection, USP (2.5 mg/mL), 30 mL single-dose vials due to the presence of partic...[ Price : $8.95]
FDA places another Ranbaxy drug manufacturing plant in India under terms of a 2012 consent decree after two inspections last year ...[ Price : $8.95]
FDA clears a Vital Access Corp. 510(k) for its Vwing Vascular Needle Guide for patients undergoing dialysis.[ Price : $8.95]
Millennium Pharmaceuticals petitions FDA seeking additional pre-approval requirements on a Fresenius 505(b)(2) NDA for bortezomib ...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: Bioanalytical Method Validation.[ Price : $8.95]
A bipartisan group of House lawmakers introduce a bill that would clarify FDAs authority over large-scale pharmacy drug compoundin...[ Price : $8.95]
FDA clears a de novo 510(k) for NeoTracts UroLift system, the first permanent implant to relieve low or blocked urine flow in men ...