Bristol-Myers Squibb (BMS) has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for its investigational DCV Dual Regimen (daclatasvir and asunaprevir) for use as a combination therapy in the treatment ...
Tags: Bristol-Myers, Medicine
Salix Pharmaceuticals and Pharming Group have announced that the US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) Action Date to 16 July 2014 for the Biologics License Application (BLA) for the ...
Tags: Drug, Pharming Group
US-based biotechnology firm Vertex Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for a supplemental New Drug Application (sNDA) of its Kalydeco (ivacaftor) for the treatment of people with cystic ...
Tags: FDA Approval, Vertex, Kalydeco sNDA
Stryker has announced the global launch of its new Trevo XP ProVue retriever, which expands the ProVue retriever line with additional size and shape options for physicians. Stryker claims that the Trevo ProVue retrievers are the ...
Del Monte Pacific (DMPL), a Singapore-based food and beverage firm, has closed the acquisition of Del Monte Foods' (DMF) Consumer Products business for $1.67bn. The acquired entity will now be renamed as Del Monte Foods (DMFI). The ...
Tags: Del Monte Pacific, US Food Unit
Admedus has obtained the US Food and Drug Administration (FDA) clearance to market an advanced cardiovascular scaffold, CardioCel, which is designed to repair and treat a range of cardiovascular and vascular defects. The approval is ...
Tags: Cardiocel, FDA Clearance
US-based AliveCor has obtained the US Food and Drug Administration (FDA) approval to sell its AliveCor heart monitor without prescription, previously available by prescription only. It is claimed to be the only FDA cleared mobile ECG ...
Tags: Heart Monitor, AliveCor
BrainStorm Cell Therapeutics has received a notice of allowance from the US Patent Office for its ‘Mesenchymal Stem Cells for the Treatment of CNS Diseases’ (serial number 12/994,761) patent application. This patent relates to ...
Tags: Cell Technology Patent, Medicine
German biotechnology company Miltenyi Biotec has received the US Food and Drug Administration's(FDA)approval for its CliniMACS CD34 reagent system to prevent graft-versus-host disease(GVHD)in the treatment of acute myeloid leukemia(AML). ...
Tags: Miltenyi Biotec, Blood, Medicine
The Gagnon Cardiovascular Institute at Morristown Medical Center became the first hospital in the tri-state area to adopt a new minimally invasive medical device to treat patients with severe aortic stenosis who are too ill or frail to ...
Del Monte Pacific (DMPL), a Singapore-based food and beverage firm, has received approval from the Singapore Exchange to proceed with its proposed takeover of Del Monte Foods' (DMF) Consumer Products business in a $1.67bn deal. In October ...
Tags: Agriculture, food, beverage
Researchers at the Prairie Research Institute's Illinois Natural History Survey have found that overall, concentrations of arsenic, selenium, and mercury in bighead and silver carp from the lower Illinois River do not appear to be a health ...
Tags: Chemosphere, EPA, Jeff Levengood, health
US-based Medac Pharma has reported the US Food and Drug Administration (FDA) acceptance of a new drug application (NDA) for its lead product candidate, MPI-2505, a subcutaneous injectable methotrexate (MTX) in a ready-to-use injection ...
Teva Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for its supplemental new drug application (sNDA) for three-times-a-week COPAXONE 40mg/mL, a new dose of COPAXONE. COPAXONE (glatiramer acetate ...
Benvenue Medical, a medical device company, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Kiva VCF treatment system for the reduction and treatment of spinal fractures. The FDA marketing clearance is ...