Qiagen has won the US Food and Drug Administration (FDA) approval for its new molecular companion diagnostic product, therascreen KRAS RGQ PCR test kit, to provide guidance on the use of Erbitux for approximately 110,000 US patients with ...
Tags: Qiagen, FDA, molecular companion diagnostic product, test kit
Biopharmaceutical company Protalix BioTherapeutics has received clearance of its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to initiate clinical trials of PRX-102. The Company is planning to ...
Tags: Protalix BioTherapeutics, investigational new drug, IND, PRX-102
The US District Court for the District of New Jersey has ruled against Merck, known as MSD outside the US and Canada, in a patent litigation against Apotex. The patent at issue in the case covers the active ingredient in Nasonex, ...
The US District Court for the Southern District of New York has ruled in favor of Teva Pharmaceutical Industries in Copaxone patent infringement litigation. Teva filed lawsuit against Momenta/Sandoz and Mylan/Natco for infringement of ...
Tags: patent, Teva Pharmaceutical Industries, FDA
Proacta, a San Diego based biotechnology company, has announced FDA approval of investigational new drug (IND) application for PR610, a hypoxia-activated irreversible multi-kinase inhibitor, for the treatment of cancer. With the IND ...
Tags: investigational new drug, IND
The US Food and Drug Administration (FDA) has granted approval to HeartWare International's miniaturized ventricular assist system. The HeartWare system, which includes a HVAD circulatory assist device with a sintered inflow cannula, ...
Tags: ventricular assist system, cardiac transplantation, FDA
GlaxoSmithKline (GSK) and XenoPort have gained FDA approval for Horizant (gabapentin enacarbil) extended-release tablets for postherpetic neuralgia (PHN). A single 12-week principal efficacy trial and two supportive studies that met their ...
Ken's Foods, a US-based producer of salad dressing, prepared sauces and mayonnaise, is voluntarily recalling its own branded foodservice dressings and sauces over Listeria monocytogenes contamination, according to the US Food and Drug ...
Tags: producer of salad dressing, prepared sauces, mayonnaise
Along with the in-depth implementation of new medical reform, the potential demand in central and western China and rural areas has been further released, and the medical diagnosis, monitoring and treatment equipment manufacturing industry ...
Tags: new medical reform, medical diagnosis, monitoring, treatment equipment
InkSure Technologies has launched the new security taggants that can be incorporated into blister packaging and induction seals on bottles. The taggants are approved by the US Food and Drug Administration (FDA) for direct food contact to ...
Tags: InkSure Technologies, security taggants, blister packaging
Raymond-Hadley of New York is recalling Wegmans Gluten Free Double Chocolate Brownie mixes as the products contain milk as ingredient that is not mentioned on the label, according to the US Food and Drug Administration (FDA). The recall ...
Tags: milk as ingredient, chocolate chunks, life threatening reaction
JFC International, a California-based food company, is recalling its Furikake-Seto Fumi 1.7oz. as the product contains egg yolk, soybeans and wheat which are not declared not the label, according to the US Food and Drug and Administration ...
LSG Sky Chefs, an establishment based in Orlando, Florida, is recalling approximately 735 pounds of ready-to-eat chipotle chicken wrap products over Listeria monocytogenes contamination, according to the US Department of Agriculture's Food ...
US-based Turkana Food is recalling Turkish 'Turkana Valley' dried apricots as the product contains sulfites as preservatives, according to the US Food and Drug Administration (FDA). The recall was initiated after New York State Department ...
Tags: sulfites, dried apricots
Sunland's peanut butter plant in New Mexico,which has been linked to a salmonella outbreak in the US,remains idle as the management waits for federal clearance to begin operations. Sunland suspended the operations of the plant and ...
Tags: peanut butter, idle, salmonella, FDA