It can concurrently detect 12 other types of high-risk HPVs, according to the FDA. The FDA recommended that women who test positive for HPV 16 or HPV 18 using the cobas HPV test have a colposcopy. "They conducted a well-designed study that provided the FDA with a reasonable assurance of the safety and effectiveness when used as a primary screening
New Anthrax Vaccines Study Findings Recently Were Reported by Researchers at Food and Drug Administration. By a News Reporter-Staff News Editor at Medical Letter on the CDC& FDA Investigators publish new report on Immunization and Public Health- Anthrax Vaccines. Our news journalists obtained a quote from the research from Food and Drug Administr
By a News Reporter-Staff News Editor at Medical Letter on the CDC& FDA Fresh data on Mosquito-Borne Diseases- Zika Virus are presented in a new report. We interrogated a library of FDA- approved drugs for their ability to block infection of human HuH-7 cells by a newly isolated ZIKV strain. " For more information on this research see: A Screen of
Allergan, the pharmaceutical giant that has announced a $200 million expansion of its Waco plant, will buy three companies in deals valued at almost $2.4 billion as it acquires assets to complement its operations in the United States and abroad and invests more in research and development. The acquisition of Vitae is a strategic investment for Alle
Data on Atrial Fibrillation Reported by Researchers at St. Antonius Hospital. Our news journalists obtained a quote from the research from St. Antonius Hospital, "However, tools for risk assessment and thus better guidance for decision-making are lacking, especially for elderly atrial fibrillation patients. Berg, J.M., St. Antonius Hospital, Dept.
The U.S. Food and Drug Administration today approved Amjevita as a biosimilar to Humira for multiple inflammatory diseases. This is the fourth FDA- approved biosimilar. The biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions, said Janet Woodcock, M.D., direc
-KaloBios Pharmaceuticals, Inc., a biopharmaceutical company focused on advancing medicines for patients with neglected and rare diseases, announced the filing with the U.S. Securities and Exchange Commission of the companys Forms 10- Q for the three months ended March 31, 2016, and for the three and six months ended June 30, 2016. Among the many..
-Loxo Oncology, Inc., a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today announced thatthe company will be participating in the following upcoming investor conferences:. At the Morgan Stanley Global Healthcare Conference onSeptember 14, 2016 at 2:10PM ET in New Y
-MonoSol Rx develops and manufactures FDA- approved pharmaceutical film products. I think it is important to add that Suboxone sublingual film is a product which has saved countless lives since its approval by the FDA in 2010.. MonoSol Rx`s leadership in film drug delivery is supported by strong IP protection, a robust pipeline of prescription drug
The FDA held a two-day panel in June to discuss heater-cooler devices, which have been linked to bacterial infections known as nontuberculous mycobacteria, or NTM found in patients at hospitals in Pennsylvania and Iowa. Experts across the medical field have agreed these devices are critical to patient care, but transcripts from the FDA panel sh
Resonance Health Ltd has initiated international regulatory submissions for its new technology for assessing bone marrow iron using magnetic resonance imaging. Resonance Health specialises in the delivery of quantitative MRI techniques for the diagnosis and clinical management of diseases. Submissions of the Bone Marrow R2-MRI technology are...
Truveris, a leading provider of solutions across the prescription drug ecosystem, today announced the appointment of Faisal Mushtaq as the chief executive officer. Mr. Mushtaq brings to Truveris deep experience in health information technology and extensive entrepreneurial expertise. "Mr. Mushtaq is a seasoned digital health executive with the...
-Labeling update includes clinical data on use of Rexulti in adult patients with schizophrenia in the maintenance phase of treatment. Valby, Denmark and Princeton, New Jersey, 23 September 2016- H. Lundbeck A/S and Otsuka Pharmaceutical Development& Commercialization, Inc. announced today that the US Food and Drug Administration approved the labeli
By a News Reporter-Staff News Editor at Health& Medicine Week Additive Orthopaedics, LLC., an early stage orthopaedic device company, announced that is has received FDA 510 clearance for its 3 D printed osteotomy wedge system, to address bone fractures or osteotomies in the foot and ankle. This is the Company's second innovative device leveraging
Allergan plc today announced the company has received approval from the U.S. Food and Drug Administration to market NATRELLE INSPIRA Cohesive breast implants, offering women undergoing reconstruction, augmentation or revision surgery a new breast shaping option that combines a high gel fill ratio and Allergan's highly cohesive gel 1,2 for a...
Allergan, the pharmaceutical giant that has announced a $200 million expansion of its Waco plant, will buy three companies in deals valued at almost $2.4 billion as it acquires assets to complement its operations in the United States and abroad and invests more in research and development. The acquisition of Vitae is a strategic investment for A
By a News Reporter-Staff News Editor at Drug Week Aralez Pharmaceuticals Inc., a global specialty pharmaceutical company, announced that it acquired the U.S. and Canadian rights to ZONTIVITY , pursuant to an asset purchase agreement entered into between Merck, known as MSD outside the United States and Canada, and Aralez Pharmaceuticals Trading
Transparency Market Research Report Added "Veterinary Antibiotics Market- Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2016- 2024" Albany, NY 09/23/2016 Mounting concerns over antibiotic resistance in humans and increasing demand for meat, milk, and eggs will continue to influence discussion on veterinary healthcare.
The Latin American infusion pumps and accessories market is estimated to reach USD 671.9 million by 2021, at a CAGR of 6.6% during the forecast period. In 2015, Brazil commanded the largest share of the Latin American infusion pumps and accessories market, followed by Mexico and Argentina. Countries like Brazil and Mexico are likely to grow at lowe
BioLineRx Ltd., a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today that it has signed an exclusive, worldwide agreement with BGN Technologies, the Technology Transfer Company of Ben-Gurion University, and Hadasit, the Technology Transfer Company of...
By a News Reporter-Staff News Editor at Health& Medicine Week The CARESTREAM OnSight 3 D Extremity System that uses cone beam CT technology to capture weight-bearing and other types of extremity exams has received FDA 510 clearance and is available for order in the United States. "Our extremity imaging system can help in treating a host of ortho
By a News Reporter-Staff News Editor at Genomics& Genetics Weekly Men in the United States can now have easier access to fast and accurate testing for a potentially dangerous sexually transmitted infection, thanks to expanded claims allowed by the Food and Drug Administration for the Xpert TV assay by Cepheid, a sensitive urine-based test for Tri
Amgen today announced that the U.S. Food and Drug Administration has approved AMJEVITA? across all eligible indications of the reference product, Humira . AMJEVITA is Amgen's first biosimilar to receive regulatory approval. In addition, AMJEVITA holds the potential to offer patients with chronic inflammatory diseases an additional treatment o
The U.S. Food and Drug Administration today approved Amjevita as a biosimilar to Humira for multiple inflammatory diseases. "This is the fourth FDA- approved biosimilar. The biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions, "said Janet Woodcock, M.D., di
According to the U.S. Food and Drug Administration, there isn't enough science to show that over-the-counter antibacterial soaps are better at preventing illness than washing with plain soap and water. After studying the issue, including reviewing available literature and hosting public meetings, in 2013 the FDA issued a proposed rule requiring saf