The US Food and Drug Administration (FDA) has recommended removing certain warning statements and modifications of the instructions for the use of over-the-counter (OTC) nicotine replacement therapy (NRT) products. Commending FDA ...
Tags: FDA, Nicotine Medications Labeling, Medicine
US-based medical technology company Medtronic has secured US marketing rights for its Affinity Fusion oxygenation system following the regulatory approval from the US Food and Drug Administration (FDA). The CE-marked system, which serves ...
Tags: FDA, Fusion Oxygenation System
The US food and drug administration (FDA) has approved Janssen's Invokana (canagliflozin) for the treatment of adults with type 2 diabetes. Invokana is the oral, once-daily medication available in the US demonstrating improved glycemic ...
The US Food and Drug Administration (FDA) has approved Biogen Idec's Tecfidera (dimethyl fumarate), a new first-line oral capsule for people suffering from relapsing forms of multiple sclerosis (MS). Tecfidera reduces relapses and ...
Tags: FDA, Biogen capsule, multiple sclerosis
The European Medicines Agency (EMA) has accepted Shionogi's marketing authorisation application (MAA) for ospemifene. Ospemifene is developed as as vulvar and vaginal atrophy (VVA) therapy in post-menopausal women. Shionogi CEO Takashi ...
Tags: EMA, Medicines, ospemifene
BioControl Medical has gained the US Food and Drug Administration approval to begin the third and largest phase of INOVATE-HF (INcrease Of VAgal TonE in Heart Failure), a global, multi-center, investigational device exemption (IDE) clinical ...
Tags: BioControl Medical, FDA, Medical
Using a low-cost apparatus designed to quickly and accurately measure the properties of handheld laser devices, researchers at the National Institute of Standards and Technology (NIST, an agency of the US Department of Commerce) have tested ...
Tags: handheld laser devices, NIST, laser pointers
The US Food and Drug Administration (FDA) has granted regulatory approval to Medicrea group's PASS LP system for the treatment of adolescent idiopathic scoliosis. The system, which the company claims to be the lowest profile pedicle screw ...
The European Union (EU) has granted CE mark approval to iTraumaCare's iTClamp Hemorrhage Control System, designed for controlling critical bleeding in seconds. The device seals the edges of a wound to create a temporary pool of blood ...
Tags: iTraumaCare, medical professionals, medical
The US Food and Drug Administration (FDA) has granted 510(k) clearance to EOS imaging's new sterEOS 3D imaging software. The sterEOS 1.5 software, which is part of the company's full body, low-dose 3 D EOS imaging system, features new ...
Tags: FDA, EOS imaging, 3D imaging software, Drug
Quantel Medical, a France-based provider of technologies for the treatment of ocular diseases, has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its Vitra Multispot laser system. The device, which features ...
Tags: FDA, Multispot laser system, Medical
The US Food and Drug Administration (FDA) has granted six months pediatric exclusivity for Hospira's Precedex (dexmedetomidine HCl) injection in the US. Precedex, an alpha-2 agonist, is approved for use only in adults and the US regulator ...
Tags: Hospira Precedex injection, Drug, FDA
Pfizer and Protalix BioTherapeutics have obtained approval from the Brazilian National Health Surveillance Agency for Uplyso (alfataliglicerase) as type I Gaucher disease therapy. Uplyso, referred to as Elelyso (taliglucerase alfa) ...
Tags: Pfizer, Protalix, Protalix BioTherapeutics
The US Food and Drug Administration (FDA) has approved Mylan Specialty's abbreviated new drug application for the generic equivalent to Sunovion's Xopenex inhalation solution, Levalbuterol inhalation solution USP, 0.31mg/3mL (0.0103%), ...
The US Food and Drug Administration (FDA) has approved Par Pharmaceutical Companies' abbreviated new drug application (ANDA) for fluvoxamine maleate 100mg and 150mg extended-release (ER) capsules. Fluvoxamine maleate ER capsules are ...
Tags: FDA, Drug, fluvoxamine maleate ER