Jazz Pharmaceuticals, a specialty pharmaceutical company, has announced the issuance of new formulation patent for Xyrem (sodium oxybate) oral solution. Xyrem (sodium oxybate) oral solution is the FDA approved product for the ...
Tags: xyrem, cataplexy, patent, pharmaceutical product
Abiomed, medical device company, has won FDA 510(k) clearance for new, high flow percutaneous, catheter-based Impella device with peak flows of approximately four liters of blood per minute. The new percutaneous heart pump, which is ...
Tags: Abiomed, Impella Cardiac Power, Impella cVAD
NeuroSigma has obtained CE mark approval for its external Trigeminal Nerve Stimulation (eTNS) system, Monarch, designed for the treatment of epilepsy and major depressive disorder in adults and children of 9 years and older. The eTNS ...
Tags: NeuroSigma, eTNS, FDA
IMRIS has received the US patent to use its MR guided radiation therapy in pelvic, brain, and head and neck imaging. The FDA-approved MR guided radiation therapy includes the combination of radiation therapy and a moveable magnet system. ...
Tags: IMRIS, MR image, radiation therapy
Software solutions provider CardioComm Solutions has received clearance from Health Canada to sell and market its HeartCheck ECG pen to both consumers and patients under physician prescription across Canada. The company has translated the ...
Tags: ECG pen, translated the language, heart rhythm record, ECG health record
Sunovion Pharmaceuticals has submitted two supplemental new drug applications (sNDAs) to the FDA seeking approval for the use of LATUDA (lurasidone HCl) as monotherapy and adjunctive therapy in adult patients with depressive episodes ...
Tags: FDA, sNDA, atypical class of drugs, bipolar depression
Regulatory information management software and service solutions provider Extedo has launched a new version of Globalvalidator, an eCTD and NeeS validation solution. The validation solution, Globalvalidator, provides life sciences firms ...
Tags: Extedo, service solutions provider, life sciences firms, new version
The United States Patent Office has issued a patent covering Nuvo Research's compositions and methods of using Pennsaid (diclofenac sodium topical solution) 2.0% w/w (Pennsaid 2% Patent), which will expire on 21 April 2028. Pennsaid is a ...
Azzur Labs, a subsidiary of Azzur Group, has opened a new laboratory in Lehigh Valley, Pennsylvania, US. Azzur Labs is involved in providing analytical compliant testing services for the medical device, pharmaceutical, biotechnology and ...
Tags: laboratory, analytical compliant testing services, medical device
The Iowa state in the US has made it mandatory for state's dairy processors to test all milk received in the state for aflatoxin,a carcinogenic compound which is produced by fungus that grows on grain and peanuts. Aflatoxin can sometimes ...
Tags: aflatoxin, carcinogenic compound, fungus
Brand New Energy(BNE),a dietary supplement re-sale distributor,is recalling all lot codes of dietary supplement EphBurn 25 due to possible health risk,according to the US Food and Drug Administration(FDA). The recall was initiated after ...
Tags: FDA, dietary supplement, health risk, ephedrine alkaloids, stimulant
The US Food and Drug Administration (FDA) has cleared Crospon's EndoFLIP system for use in gastroenterology applications. The EndoFLIP system utilizes the new Barostat software to include pressure and dimension measurements taken in the ...
Tags: EndoFLIP system, Barostat software, FDA, gastroenterology applications
Janssen Research and Development has received the Priority Review for the supplemental New Drug Application (sNDA) for ZYTIGA from US Food and Drug Administration (FDA). Zytiga (abiraterone acetate) is administered in combination with ...
Tags: sNDA, priority review, FDA
Covidien has won FDA 510(k) clearance for the iDrive Ultra powered stapling system, a reusable, battery-operated endoscopic surgical stapler. The iDrive Ultra system leverages proprietary Tri-Staple technology that provides less stress on ...
Cucina Fresca Gourmet Foods is recalling tomato sauce products in the US as they may contain milk,which is not declared on the label,according to the US Food and Drug Administration(FDA) Consumption of these products may lead to a ...