Taking an important first step toward reducing Americans' unnecessary exposure to arsenic in foods, the U.S. Food and Drug Administration is proposing an "action level" of 10 parts per billion for inorganic arsenic in apple juice, which is ...
Tags: Apple Juice, Arsenic
The U.S. Food and Drug Administration (FDA) will publish a final rule amending the food additive regulations to no longer provide for the use of bisphenol-A (BPA)-based epoxy resins as coatings in infant formula packaging because this use ...
CryoLife has received premarket approval from the US Food and Drug Administration (FDA) for its new Sologrip, a minimally invasive laser fiber-optic delivery system. The Sologrip delivery system is a single-use, disposable handset ...
The US Food and Drug Administration (FDA) is set to publish a final rule amending the regulations on food additives to no longer provide for the use of bisphenol A (BPA)-based epoxy resins as coatings in infant formula packaging. Based on ...
Tags: Infant Food Packaging, Packaging
Janssen Research & Development is seeking FDA approval for use of ibrutinib in the treatment of previously treated patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL). The ...
Tags: FDA Approval, Janssen
Specialty pharmaceutical company Tris Pharma's generic pharmaceuticals business has launched Dextroamphetamine Sulfate Oral Solution to treat attention deficit disorder with hyperactivity (ADHD) and narcolepsy in the US. Available through ...
Tags: Tris Pharma, Medicine
The US FDA has accepted to review Bristol-Myers Squibb Company and Pfizer's Eliquis (apixaban) supplemental new drug application for prophylaxis of deep vein thrombosis (DVT) subsequent to hip or knee replacement surgery. The application ...
Tags: Drug Application, Medicine
Norwegian cardiovascular biopharma Serodus has signed a merger agreement with Danish peptide specialist Phlogo to expand cardiovascular drug candidate portfolio. Subject to approval by an EGM, the merger is expected to accelerate Serodus' ...
Veeco has received an R&D 100 Award for its SPECTOR-HT Ion Beam Deposition (IBD) System. Initiated in 1962 and called the "Oscars of Innovation," the R&D Awards, issued by R&D Magazine, recognize and celebrate the top 100 technology ...
The American Trucking Associations (ATA) "praised" new measures proposed by the National Transportation Safety Board (NTSB) to reduce impaired driving. The ATA is also calling for the Department of Transportation (DOT) to allow mandatory ...
Tags: Transportation, Auto
Accenture has launched a new business service, known as Accelerated R&D Services, to accelerate drug development from discovery to approval to market. Focused on delivering streamlined and integrated research and development (R&D) ...
Tags: Drugs, R&D Service
Sectra has registered Sectra DoseTrack, a new class 1 software medical device, with the US Food and Drug Administration (FDA). Sectra DoseTrack is a web-based solution to monitor patient radiation doses and check whether they are kept as ...
Tags: Sectra, Sectra DoseTrack
NeuroMetrix, a US-based medical device company, has received 510(k) approval from the US Food and Drug Administration (FDA) for its transcutaneous electrical nerve stimulator, called Sensus Pain Management System. Sensus Pain Management ...
Tags: medical device, Pain Management
Cha Bio&Diostech, a South Korean partner of Pluristem Therapeutics, has filed its first investigational new drug (IND) application for Pluristem’s PLacental eXpanded (PLX) cells with the Korean Food and Drug Administration (KFDA). ...
Tags: PLX Cells, Cha Bio&Diostech
Novartis has received an approval from the European Commission for its Lucentis (ranibizumab) to treat patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (myopic CNV). Lucentis is a ...