The US Food and Drug Administration (FDA) has approved Navidea Biopharmaceuticals' Lymphoseek (technetium Tc 99m tilmanocept) injection, a novel product indicated for use in lymphatic mapping procedure. The lymphatic mapping procedure ...
Tags: FDA, Biopharmaceuticals, Navidea Biopharma
The US Food and Drug Administration (FDA) has accepted Neos Therapeutics' new drug application (NDA) 505(b)(2) filing for NT0202, an extended release (XR) orally disintegrating tablet (ODT) formulation of Amphetamine Polistirex. The ...
AVX, a US-based manufacturer of advanced passive components and interconnect solutions for the medical device industry, has received ISO 13485:2003 certification for its high-reliability tantalum capacitor manufacturing facility in ...
Tags: medical device industry, medical device, medical industry
The US Food and Drug Administration (FDA) has granted 510(k) clearance to RTI Biologics' porcine dermis implant for use in soft tissue repair procedures such as hernia repair. The implant is comprised of non-crosslinked porcine dermis and ...
Tags: FDA, biologics portfolio, RTI Biologics
Chimerix, a US-based company which discovers, develops and commercializes oral antiviral therapeutics, has won the US Food and Drug Administration (FDA) fast track designation for CMX001 for the prevention of cytomegalovirus (CMV) ...
Tags: Chimerix, oral antiviral therapeutics, FDA, CMX001
Biogen Idec is seeking marketing approval from the US Food and Drug Administration (FDA) for recombinant factor VIII Fc fusion protein (rFVIIIFc) therapy to treat hemophilia A. The company has submitted a biologics license application ...
Tags: Biogen Idec, FDA, hemophilia A
Institute of Food Technologists organization of Chicago, IL USA has certified br. Syed Rasheeduddin Ahmed as a Certified Food Scientist. They wrote to Br. Ahmed the following message: " You have demonstrated your practical knowledge and ...
Tags: MCG, Certified Food Scientist, halal
The US Food and Drug Administration (FDA) has granted 510(k) approval to Vital Images' CT transcatheter aortic valve replacement (TAVR) planning application. TAVR procedures, in general, use endovascular techniques to replace faulty ...
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Nuvo Research's US licensing partner, Mallinckrodt, following the review of Mallinckrodt's New Drug Application (NDA) for diclofenac sodium topical ...
CircuLite has obtained conditional approval from the US Food and Drug Administration (FDA) for its Synergy Circulatory Support System, designed for reversing the symptoms of heart failure in ambulatory chronic heart failure patients. The ...
Tags: CircuLite, FDA Conditional Approval, Micro-Blood Pump Device
The US Food and Drug Administration (FDA) has accepted to review Iroko Pharmaceuticals New Drug Application (NDA) for lower dose submicron diclofenac, a non-steroidal anti-inflammatory drug (NSAID), with a proposed indication of treatment ...
Tags: FDA, Pharmaceuticals, Medicine
The US Food and Drug Administration (FDA) has accepted for review AMAG Pharmaceuticals' supplemental new drug application (sNDA) for Feraheme (ferumoxytol) injection for Intravenous (IV) use. The sNDA filed is to expand the indication for ...
Tags: FDA, Pharmaceuticals, oral iron treatment
The US Food and Drug Administration (FDA) has accepted Biogen Idec's biologics license application (BLA) for the marketing approval of recombinant factor IX Fc fusion protein (rFIXFc) for the treatment of hemophilia B. Using the company's ...
Tags: FDA, Idec BLA, hemophilia B
The US Food and Drug Administration (FDA) has approved Tenaxis Medical's ArterX Surgical Sealant, designed for use in vasculature reconstruction in various surgical procedures. ArterX Surgical Sealant is a two-part liquid system that will ...
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Royal Philips Electronics' full-field digital mammography (FFDM) system. Having the capability to enable future Single-Shot Spectral Imaging applications like ...
Tags: FDA, clinicians, FFDM