US based Ariad Pharmaceuticals has submitted New Drug Application (NDA) for its investigational BCR-ABL inhibitor, ponatinib for the approval of US Food and Drug Administration (FDA). Ponatinib is indicated for patients with resistant or ...
Tags: BCR-ABL inhibitor, CML, Ph+ALL
US food company Sugar Creek Packing plans to invest $28.5m to expand and upgrade a 77,000ft2 plant in Cambridge City, Indiana, which was formerly owned by Really Cool Foods. The plant, located in Indiana Gateway Industrial Park, Wayne ...
Tags: plant closure, renovation project, refrigeration space
Horizon Pharma RAYOS (prednisone) delayed-release tablets have received the US Food and Drug Administration (FDA) approval. The approved drug is used to treat rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), psoriatic arthritis ...
Tags: Horizon Pharma RAYOS delayed-release tablets, rheumatoid arthritis, RA
The US Food and Drug Administration (FDA) has granted approval to Lupin Pharmaceuticals to market a generic version of CP Pharmaceuticals' Lyrica (Pregabalin) capsules. Lupin's generic equivalent of Lyrica capsules are manufactured as ...
Tags: FDA, Lupin Pharmaceuticals, lyrica capsules
Jimmy Dean, the brand owned by US food company Hillshire Brands, is recalling a partial production of its butcher wrapped Foodservice product, Jimmy Dean French Toast & Sausage Sandwich, over undeclared allergens egg and soy. The product ...
Tags: food company, partial production, undeclared allergens egg and soy
Food scientists at Cornell University, US, have identified predominant spore-forming bacteria in milk and their unique enzyme activity, a finding that could help to extend the shelf-life of dairy products and improve their quality. The ...
Tags: predominant spore-forming bacteria, dairy products, raw milk
Kelyniam Global has registered craniofacial implant's 510(k) application with the US Food and Drug Administration (FDA). Craniofacial implant, made of Invibio PEEK Optima material, is designed for the treatment of patients with congenital ...
Tags: Kelyniam, FDA, craniofacial implant's 510(k)application
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
Rheonix, a developer of molecular diagnostic platforms, will present data of its automated KRAS CARD molecular diagnostic assay. The KRAS CARD is designed to detect seven known somatic mutations of KRAS oncogene from either fresh or ...
Tags: Rheonix, KRAS CARD, diagnostic assay, KRAS assay
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 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
US-based Tri-Union Seafoods has voluntarily recalled a limited amount of Chicken of Sea Brand 7-ounce cans of solid white albacore tuna in water, as the product contains soy which is not mentioned in the ingredients list. The product ...
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
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
The Canadian Food Inspection Agency(CFIA)has warned the public not to consume some of the peanut butter products produced by US food company Sunland,as they may be contaminated wtih Salmonella. This recall is related to the expanded ...
Tags: CFIA, peanut butter, Salmonella