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%), ...
Synta Pharmaceuticals, a US-based biopharmaceutical company, has named Dr Sumant Ramachandra as the new president of research and development (R&D). Dr Ramachandra served as senior vice president, R&D, regulatory and medical affairs, and ...
Tags: Synta Pharma, biopharmaceutical company, biopharmaceutical
The European Commission has approved ThromboGenics' Jetrea (ocriplasmin) for the treatment of vitreomacular traction (VMT), including when coupled with macular hole of diameter less than or equal to 400 microns, in the European Union (EU). ...
Tags: ThromboGenics Jetrea, vitreomacular traction treatment, drug
TransTech Pharma has received FDA fast track designation for new small-molecule chemical compound TTP488, for the treatment of Alzheimer's disease. TTP488 prevents interaction of a material found in the Alzheimer's patients cells, ...
Tags: Transtech Alzheimer, FDA, Medicine
U.S. House lawmakers plan to hold a three-day series of hearings to determine how the U.S. Food and Drug Administration should regulate mobile health applications. The House Energy and Commerce Committee plans to begin the hearings ...
Tags: Computer Products, software
Owens-Illinois forms partnership to produce high-quality recycled glass Owens-Illinois Inc. is teaming with eCullet Inc. to form a joint venture involving processing of recycled glass. Glass to Glass LLC will invest in sophisticated glass ...
Tags: Packaging, Printing, Owens-Illinois
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
Specialty pharmaceutical company Sagent Pharmaceuticals has opted for Elsevier's Gold Standard's drug information technologies, ProspectoRx and Clinical Pharmacology to access current and accurate drug data and pricing. ProspectorRx ...
The US Food and Drug Administration (FDA) has approved Navidea Biopharmaceuticals' Lymphoseek (technetium Tc 99m tilmanocept) injection, a novel product indicated for use in lymphatic mapping procedure. The lymphatic mapping procedure ...
Tags: FDA, Biopharmaceuticals, Navidea Biopharma
The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has granted marketing authorization to Meda Pharmaceuticals' nasal spray formulation Dymista for the symptomatic treatment of moderate to severe seasonal and perennial ...
The US Food and Drug Administration (FDA) has accepted Neos Therapeutics' new drug application (NDA) 505(b)(2) filing for NT0202, an extended release (XR) orally disintegrating tablet (ODT) formulation of Amphetamine Polistirex. The ...