The US Food and Drug Administration (FDA) has expanded age indication for Novartis' Menveo (Meningococcal [Groups A, C, Y and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine) to include infants and toddlers aged two months and ...
Hologic has received the US Food and Drug Administration (FDA) clearance for its Single Energy (SE) femur exam, designed to visualize features associated with AFFs quickly and conveniently at the time of osteoporosis assessment. The quick ...
Tags: Hologic, FDA Clearance
Convergent Dental has received the US Food and Drug Administration (FDA) clearance for its Solea, a CO2 laser system for ablation of hard tissue for caries removal and cavity preparation. Claimed to be the first 9.3μm CO2 computer ...
US generics drug maker Actavis has rolled out new formulations of Fioricet (butalbital, acetaminophen and caffeine capsules, USP) and Fioricet with Codeine (butalbital, acetaminophen, caffeine and codeine phosphate, USP). Both medicines ...
Oral drug delivery systems developer Oramed Pharmaceuticals has submitted a pre-Investigational New Drug (pre-IND) seeking approval from the US Food and Drug Administration (FDA) to commence a trial on its orally ingestible exenatide ...
US-based food distributor Lipari Foods is recalling cooked shrimp product as it may be contaminated with Salmonella, according to the US Food and Drug Administration (FDA). The product associated with the recall is Wholey brand Cooked ...
Tags: Lipari Foods, Cooked Shrimp, Salmonella Contamination Concerns
Defense Advanced Research Projects Agency (DARPA) has awarded $22.83m contract to Battelle, NxStage Medical and Aethlon Medical collaboration team to develop an advanced portable device to treat sepsis for military needs. DARPA created ...
Tags: Portable Device, Sepsis
NeuroSigma has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to begin a Phase III pivotal trial of its Monarch eTNS System. Designed to treat the drug resistant epilepsy, the ...
Tags: Device Trial, NeuroSigma
IntelligentMDx has secured clearance from the US Food and Drug Administration (FDA) for IMDx VanR for Abbott m2000 assay, an automated molecular diagnostic test that detects the presence of vanA and vanB genes associated with ...
EnteroMedics has submitted premarket approval (PMA) application to the US Food and Drug Administration (FDA) for Maestro Rechargeable System's VBLOC, a vagal blocking therapy to treat obesity. Maestro RC system delivers vagal blocking ...
Tags: EnteroMedics, Vbloc Therapy
Dr Reddy's Laboratories, an India-based pharmaceutical company, has introduced Donepezil Hydrochloride tablets 23mg in the US on 26 July 2013. The launch follows the approval of an abbreviated new drug application (ANDA) for the drug by ...
Tags: Drug Aricept, Generic Equivalent
Hologic's Aptima HPV assay has received clearance from the US Food and Drug Administration (FDA) for use on its fully-automated Panther system, enabling laboratories to run multiple tests from a single specimen. A nucleic acid amplified ...
Tags: Panther System, Aptima HPV Assay
Abbott has obtained approval from US Food and Drug Administration (FDA) for its inpatient blood glucose monitoring system, called FreeStyle Precision Pro Blood Glucose and Beta-Ketone Monitoring System, which provides test results in real ...
Tags: Abbott, Monitoring System
Cepheid, a California-based medical device firm, has received market authorization from the US Food & Drug Administration (FDA) for its Xpert MTB/RIF test, a tuberclosis test. The regulatory agency approved following a de novo 510(k) ...
Tags: Cephid, Tuberclosis Test
The US Food and Drug Administration (FDA) has dispatched warning letters to 15 firms, including foreign and domestic to desist from selling their illegally marketed diabetes products. The latest move will help the regulator to curb the ...
Tags: Diabetes'Medicines, active pharma