US-based Boston Scientific has obtained Chinese Food and Drug Administration (FDA) approval for its Alair bronchial thermoplasty system, designed for patients suffering from severe asthma. The Alair system uses mild heat to reduce the ...
Tags: Boston Scientific, Alair bronchial thermoplasty system
Texas Children's Hospital and Baylor College of Medicine are part of a consortium received a five-year, $1.5m grant from the U.S. Food and Drug Administration to improve the pipeline for the development of pediatric medical devices. The ...
Tags: Medical Device, Medicine
Allergan has received a positive opinion for its Vistabel (botulinum toxin type A) from France's National Security Agency of Medicines and Health Products (ANSM) to treat moderate to severe crow's feet lines in adult patients. The ...
Tags: Allergan, Crow's Feet Lines
The US FDA's Antiviral Drugs Advisory Committee has recommended approval for Medivir's investigational protease inhibitor simeprevir (TMC435) 150mg capsules for the treatment of genotype 1 chronic hepatitis C in adult patients with ...
Tags: Medivir, Hepatitis C Patients
US-based specialty chemicals provider Eastman Chemical has expanded its non-phthalate plasticizer portfolio with the launch of new Eastman Versafix plasticizer. Eastman Versafix is claimed to provide required viscosity control and ...
GlaxoSmithKline (GSK) has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for the once daily inhaled corticosteroid (ICS) treatment, fluticasone furoate (FF), administered using the ELLIPTA dry powder ...
Tags: Asthma Treatment, Medicine
Hospira, a provider of injectable drugs and infusion technologies, has announced the launch of the Sapphire infusion system in the US following regulatory approval from the US Food and Drug Administration (FDA). The Sapphire features an ...
Tags: ambulatory pumps, Hospira
Eli Lilly and Company has received priority review status from the US Food and Drug Administration (FDA) for its ramucirumab (IMC-1121B) as a single-agent treatment for advanced gastric cancer following disease progression after initial ...
Tags: Cancer Drug, FDA Priority
Cardiovascular Systems, a US-based medical device company, has obtained a premarket approval from the US Food and Drug Administration (FDA) for its Diamondback 360 coronary orbital atherectomy system (OAS), designed to treat severely ...
Reser’s Fine Foods, a Kansas-based company, is recalling about 22,800 pounds of chicken, ham and beef products, as they may be contaminated with Listeria monocytogenes, the US Department of Agriculture’s Food Safety and ...
Tags: Reser's Fine Foods, Meat Products
US-based pharmaceutical firm Merck has received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for its investigational oral combination regimen MK-5172/MK-8742 for the treatment of chronic hepatitis C virus ...
US-based iCeutica announced that its partner Iroko Pharmaceuticals has received the US Food and Drug Administration (FDA) approval to market ZORVOLEX (diclofenac) capsules, a non-steroidal anti-inflammatory drug (NSAID) that utilizes ...
Bayer HealthCare has announced that the US Food and Drug Administration (FDA) has cleared its CONTOUR next link blood glucose monitoring (BGM) system as a component of Medtronic's new MiniMed 530G with Enlite, a breakthrough diabetes ...
Tags: Bayer HealthCare, Medicine
Medical device company Varian Medical Systems has obtained 510(k) approval from the US Food and Drug Administration for RapidPlan, a radiotherapy treatment planning tool designed to enhance quality, consistency, and efficiency in ...
SCS Global Services (SCS), a pioneer and industry leader in third-party auditing and certification of food quality and food safety claims, announced expanded laboratory capabilities and competitive pricing under its new testing arm, SCS ...
Tags: SCS Global Services, food quality