Clinical-stage biopharmaceutical company Pharmacyclics' new drug application (NDA) for the investigational oral Bruton's tyrosine kinase (BTK) inhibitor, ibrutinib, has been accepted by the US FDA for two B-cell malignancy indications. ...
Tags: Solvay Group, Medicine
Japanese pharmaceutical firm Eisai Co, through its South Korean marketing subsidiary, has rolled out a higher-dose, once-daily Aricept (donepezil hydrochloride) 23mg tablet formulation used to treat moderate-to-severe Alzheimer's disease ...
Tags: pharmaceutical firm, Medicine
Horizon Pharma and SkyePharma have filed a patent infringement lawsuit against Watson Laboratories (WLF) and certain related companies like Actavis Pharma, Andrx and Actavis Inc. The lawsuit was filed in the US District Court for the ...
Tags: Horizon Pharma
The U.S. Food & Drug Administration (FDA) has categorized Cepheid's Xpert MTB/RIF test as 'moderate complexity' under the Clinical Laboratory Improvement Amendments (CLIA). Xpert MTB/RIF test is designed for the rapid molecular detection ...
Tags: moderate Complexity, Medicine
Boston Scientific has received the US Food and Drug Administration (FDA) approval for its IntellaTip MiFi XP catheter and 510(k) clearance for its Zurpaz 8.5F steerable sheath. The IntellaTip MiFi XP is a high resolution catheter that ...
Tags: Cardiac Devices, Drug
Reverse Medical has received the 510(k) clearance from the US Food and Drug Administration (FDA) for its MVP Micro Vascular Plug system, which is designed for peripheral artery embolization. MVP Micro Vascular Plug system is used to ...
Tags: Reverse Medical, Medicine
Denmark-based health care company Novo Nordisk has won US FDA 510(k) clearance for the insulin injection device, NovoPen Echo, combining half-unit dosing with a memory function to help patients manage their diabetes. Available to patients ...
Tags: Insulin Injection, Medicine
PFM Medical, a developer and manufacturer of minimally invasive medical devices for cardio vascular technology, vascular access, surgery, and oncology, has received the US Food and Drug Administration (FDA) premarket approval for its ...
Tags: PFM Medical, Medicine
RNAi therapeutics company Alnylam Pharmaceuticals has obtained additional orphan drug designation from US FDA for a RNAi therapeutic, ALN-AT3, to treat hemophilia A. With the additional approval, orphan drug designation for GalNAc ...
Tags: Alnylam, Orphan Drug
Buurma Farms is voluntarily recalling 465 boxes of Cilantro as the product may be contaminated with Listeria monocytogenes. The recall affects Cilantro 4oz. bunches with a Product of USA Buurma Farms #4889 labeled twist tie, featuring ...
Tags: Buurma Farms, Cilantro
The US Food and Drug Administration (FDA) has approved GlaxoSmithKline's Flulaval Quadrivalent (Influenza Virus Vaccine) for the active immunization of people three years of age and more to help prevent disease caused by seasonal influenza ...
Tags: Flulaval Quadrivalent
Whole Foods Market in Northern California is recalling sour cherry and blueberry crostatas as the manufacture involved the use of egg wash which was not declared on the label. Consumers intolerant to eggs are at risk of serious or ...
Tags: Whole Foods, Baked Items
The US FDA has approved Silvergate Pharmaceuticals' Epaned (enalapril maleate Powder for Oral Solution) to treat hypertension (high blood pressure) in people aged one month and more. Silvergate Pharmaceuticals president and CEO Frank ...
Natus Neurology has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and Health Canada clearance for its new electrodiagnostic system, the UltraPro S100 EMG system. The UltraPro S100 is an EMG/nerve conduction ...
The US Food and Drug Administration (FDA) has cleared Given Imaging’s next-generation video capsule, called PillCam SB 3. The 11 mm x 26 mm video capsule is helpful in detecting small bowel abnormalities related to Crohn's disease, ...
Tags: PillCam SB 3, Drug