Fresenius Kabi USA has announced the availability of Levofloxacin in 5% dextrose injection in freeflex containers. Freeflex is a PVC-free, plasticizer-free, non-DEHP container, which is designed for easy handling and infusing the ...
Tags: Fresenius Kabi, Freeflex Container
SpineGuard has received 510(k) clearance from the US Food and Drug Administration (FDA) for three new products, designed to enhance pedicle screw penetration of small and/or difficult-to-access pedicles. The two miniaturized versions of ...
Tags: Pediguard Products, SpineGuard
The California State Assembly has passed a bill that restricts generic versions of medicines called biosimilars, upon their launch in the US. Biosimilars are medicines whose active drug substance is derived from living cells. They have ...
Tags: Biosimilar Drugs Bill, Medicine
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
Members of the International Bottled Water Association (IBWA) stand ready to assist people living and working in areas affected by the California Wildfires, to make sure they have access to clean, fresh, safe and reliable drinking water. ...
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 US Food and Drug Administration (FDA) has issued Breakthrough Therapy Designation for Catalyst Pharmaceutical Partners’ Firdapse (amifampridine phosphate), which is used to treat patients with Lambert-Eaton Myasthenic Syndrome ...
Tags: Therapy Designation, Medicine
Medical device company LDR has received approval from the US Food and Drug Administration (FDA) for commercial sale and distribution of its Mobi-C Cervical Disc (Mobi-C), for two-level indications in the US. The Mobi-C is designed for ...
Tags: Medical device, LDR
HeartWare International has received the U.S. Food and Drug Administration (FDA) approval to enroll supplemental patient cohort for ENDURANCE, a pivotal destination therapy clinical study. HeartWare will enroll up to 286 patients ...
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
Bayer HealthCare and Onyx Pharmaceuticals have announced FDA priority review designation for Nexavar (sorafenib) supplemental new drug application for the treatment of radioactive iodine-refractory differentiated thyroid cancer. Nexavar ...
Tags: New Drug Application, FDA
Medical technology company Lombard Medical Technologies successfully treated the first US patients with Aorfix, its flexible stent graft for the endovascular repair of abdominal aortic aneurysms (AAAs). Meriter Hospital vascular surgeon ...
Tags: Aortic Stent Graft
InControl Medical has launched InTone, a non-surgical and no-drug solution designed for effective, non-invasive treatment of female urinary incontinence. InTone which is listed as a class II medical device by the US Food and Drug ...
Tags: InControl Medical, launched InTone
DSM Animal Nutrition & Health has announced the launch of its new 100% recyclable low-density linear polyethylene (LDPE) bags. Claimed to be durable, the white-tinted bags also provide protection from air and sunlight. Bag damage during ...
Tags: Recyclable LDPE Bags, Packaging