Biogen Idec and Elan are seeking approvals from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) for first-line use of Tysabri (natalizumab) in anti-JCV antibody negative patients with multiple sclerosis (MS). ...
BSD Medical has sold its MicroThermX microwave ablation systems and antennas to ADA Medikal, a medical specialty distributor, in Turkey. The sale of multiple MicroThermX systems and antennas forms a part of a distribution agreement signed ...
Tags: BSD Medical, MicroThermX microwave ablation systems, ADA Medikal, Turkey
The US Food and Drug Administration (FDA) has cleared the use of Hologic's amplified nucleic acid assay on the company's fully-automated Panther system. Using endocervical or vaginal swabs and specimens, collected in Hologic's ThinPrep ...
Tags: FDA, Hologic, Panther system, Trichomonas vaginalis assay
Brainsway has gained US marketing rights for its Deep transcranial magnetic stimulation (TMS) device, designed for use in patients with depression, who have failed to respond to antidepressant medications, following the US Food and Drug ...
The US Food and Drug Administration (FDA) has approved InnoPharma's abbreviated new drug application (ANDA) for acetylcysteine injection. The acetylcysteine injection, which is a generic equivalent of Cumberland Pharmaceuticals' Acetadote ...
Tags: FDA, acetylcysteine injection, Pharmaceuticals, acetaminophen
Thoratec has gained an investigational device exemption(IDE)from the US Food and Drug Administration(FDA)for the initiation of a feasibility clinical study of its continuous-flow left ventricular assist device(LVAD),for the treatment of ...
The US Food and Drug Administration has reinstated the food facility registration of Sunland, the peanut products manufacturer linked to an outbreak of salmonella last year. The FDA had suspended the operations of Sunland, the New Mexico ...
Tags: FDA, food facility registration, Sunland, peanut products manufacturer
Somersault Snack, in cooperation with the US Food and Drug Administration (FDA), is recalling Somersaults Cinnamon Crunch products as they may contain milk, which is not mentioned on the packaging of the product. Somersault Snack noted ...
Tags: Snack, Food, Somersaults Cinnamon Crunch products, milk
The US Food and Drug Administration has published two major requirements that it says will help prevent foodborne illnesses and improve food safety. The FDA on Friday (4 January) released two draft rule proposals that will allow it to ...
Tags: US Food and Drug Administration, foodborne illnesses, food safety
The US food industry has welcomed the publishing of two major requirements by the US Food and Drug Administration aimed at helping prevent foodborne illnesses and improve food safety. On Friday (4 January), the FDA released two draft rule ...
Tags: US, food industry, US Food and Drug Administration, foodborne illnesses
BioPhotas has gained the US marketing rights for its light therapy device,designed to treat acne,muscle and joint pain,muscle and joint stiffness,muscle spasm,arthritis and compromised local blood circulation,following the US Food and Drug ...
The US Food and Drug Administration(FDA)has announced two new food safety regulations that are aimed at preventing foodborne illness.The proposed rules implement the two-way FDA Food Safety Modernization Act(FSMA). The first rule requires ...
Tags: FDA, US Food, food safety regulations
The US Food and Drug Administration (FDA) has granted 510(k) approval to Alphatec Holdings' new products, Pegasus and ILLICO FS Facet Fixation systems. Pegasus, an anchored anterior cervical interbody device, offers single-step deployment ...
Tags: MIS Systems, Alphatec, FDA Approval, New Anterior Cervical Interbody
Abbott has obtained regulatory approval for its XIENCE Xpedition Everolimus Eluting Coronary Stent system,designed for improving coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary ...
Tags: Abbott, FDA, Drug Eluting System, XIENCE, symptomatic heart disease
The US Food and Drug Administration (FDA) has cleared Soft Tissue Regeneration's biodegradable scaffold for use in soft tissue augmentation and rotator cuff repair. The STR GRAFT scaffold, a patch, can be draped over the tendon, that sits ...
Tags: FDA, Soft Tissue Regeneration's, STR GRAFT scaffold, Medicine