Astex Pharmaceuticals has pocketed a milestone payment from Novartis after the cancer drug the companies worked on together a decade ago secured FDA approval. The milestone was triggered when FDA signed off on the use of Kisqali as a first-line treatment for HR-positive, HER2-negative advanced breast cancer. That led to the publication of a paper o
Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved KEYTRUDA, the companys anti-PD-1 therapy, for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma, or who have relapsed after three or more prior lines of therapy. Under the FDAs acce
Reports by the American Cancer Society reveal approximately 40 percent of U.S. women battling breast tumors are affected by metastatic breast cancer. The U.S. Food and Drug Administration confirmed the approval of Kisqali, which belongs to a class of pharmaceuticals called kinase inhibitors, on March 13. According to Novartis, a month`s supply of K
Biologics, Inc., a McKesson Specialty Health oncology pharmacy services company, has been selected by Novartis to be a specialty pharmacy provider for KISQALI . Approved by the U.S. Food and Drug Administration on March 13, 2017, KISQALI is a kinase inhibitor indicated in combination with an aromatase inhibitor as initial endocrine-based therapy
The newly FDA- cleared system is the latest addition to the premium Aplio i-series ultrasound platform, helping to elevate cardiovascular ultrasound with excellent imaging clarity and definition. The Aplio i900 presents a real breakthrough in expanding the clinical utility of ultrasound, offering cardiologists a new tool for fast, safe and confi
The Melody Transcatheter Pulmonary Valve that has been developed by Medtronic plc. Ordinary Shares (NYSE:MDT) has been approved by the U.S. Food and Drug Administration. The device is implanted in patients in cases where surgical pulmonary heart valves are not working. This transcatheter pulmonary valve is the first of its kind to be approved in [
ViewRay, Inc. announced that the company received 510 clearance from the U.S. Food and Drug Administration to market the MRIdian Linac system, the company's next generation linear accelerator-based MRI-guided radiation therapy system. "FDA clearance of the MRIdian Linac is a transformative milestone for ViewRay," said Chris A. Raanes, president an
By a News Reporter-Staff News Editor at Politics& Government Week CeloNova BioSciences, Inc. announced that it has received U.S. Food and Drug Administration approval of its first-in-class COBRA PzF? NanoCoated Coronary Stent System. "There continues to be an unmet clinical need for patients who may not be candidates for drug-eluting stents or
Release date- 15032017- The Biotechnology Innovation Organization thanks the Food and Drug Administration for the opportunity to submit comments on FDA's revised draft Guidance for Industry' Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.'. FDA -2014- D-1525-0357: Mixing, Diluting
Pfizer China announced today that it has received approval from the Chinese Food and Drug Administration to market its oral Janus kinase inhibitor, XELJANZ , in China for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. Pfizer is committed t
NEW YORK CITY- Pfizer China, a unit of Pfizer Inc., said it has received approval from the Chinese Food and Drug Administration or CFDA to market its oral Janus kinase inhibitor, Xeljanz or tofacitinib citrate, in China for the treatment of adult patients with moderately to severely active rheumatoid arthritis or RA, who have had an inadequate resp
By a News Reporter-Staff News Editor at Biotech Week Amend Surgical, Inc., a medical device company focused on enhancing the regenerative capacity of bone replacement products, announced that they have received 510 clearance to market NanoFUSE BA as a bone graft extender for spine and orthopedic applications. With this most recent clearance Am
BriaCell Therapeutics has been cleared by the FDA to begin an open-label Phase I/IIa trial of its product BriaVax in patients with advanced breast cancer. Bill Williams, President and CEO of BriaCell Therapeutics. The upcoming Phase I/IIa clinical trial is designed to determine the optimal dosing regimen for patients, further assess the vaccine
Release date- 14032017- Cambridge, UK- Astex Pharmaceuticals, a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics for oncology and diseases of the central nervous system, announced today that its long-standing pharmaceutical collaborator, Novartis, has received US Food and Drug Administration...
DJO Global, Inc., a leading global provider of medical technologies designed to get and keep people moving, today announced that its Exprt Revision Hip portfolio received market clearance by the U.S. Food and Drug Administration. The 12,000 surgeons expected to attend this year s Annual Meeting of the American Academy of Orthopaedic Surgeons
Release date- 14032017- PARSIPPANY, N.J.- Evonik Corporation's VESTAKEEP PEEK, used by medical device customers for the design and development of surgical implants, recently surpassed a milestone of more than 80 devices cleared by the U.S. Food and Drug Administration. Medical OEM's usually take one of two paths to have their devices reviewed and a
Siemens Healthineers issued the following news release:. The Food and Drug Administration has cleared the ARTIS pheno, a robotic C-arm angiography system from Siemens Healthineers created for use in minimally invasive interventional procedures. With products and solutions such as the ARTIS pheno, as well as a new name that underscores the company's
First Ray, a start-up medical device company focused on advanced surgical devices for improving outcomes for orthopaedic extremity procedures, announces that it has received FDA 510 clearance for new additions to the Stealth Staple? System product family. Previously, the company received clearance for its "Standard" size implants in different l
Release date- 14032017- DUBLIN- Medtronic plc today announced that its MelodyTranscatheter Pulmonary Valve received approval from the United States Food and Drug Administration for implantation in patients whose surgical bioprosthetic pulmonary heart valves have failed. 'As the first commercially available transcatheter heart valve, the Melody TPV.
Release date- 13032017- DUBLIN- Medtronic plc today announced U.S. Food and Drug Administration 510 clearance for its Reveal LINQ Insertable Cardiac Monitor with TruRhythm Detection, an advanced cardiac monitor offering improved accuracy to better identify abnormal heartbeats. 'For nearly twenty years, Medtronic has led innovation in cardiac monito
Medtronic plc recently announced U.S. Food and Drug Administration 510 clearance for its Reveal LINQ Insertable Cardiac Monitor with TruRhythm Detection, an advanced cardiac monitor offering improved accuracy to better identify abnormal heartbeats. "ICMs help physicians find answers for patients at risk for cardiac arrhythmias to better manage a r
We received approval from the U.S. Food and Drug Administration, for Adzenys XR-ODT, our amphetamine XR-ODT, on January 27, 2016 and launched the commercialization of this product on May 16, 2016. On November 10, 2015, we announced that we received a Complete Response Letter from the FDA in its review of our New Drug Application, or NDA, for Cotemp
Release date- 13032017- Basel- The US Food and Drug Administration has approved Kisqali in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer. 'Kisqali is emblematic of
Swiss-based healthcare company Novartis has received approval from the US Food and Drug Administration for its Kisqali in combination with an aromatase inhibitor as the first-line treatment of advanced or metastatic breast cancer. Novartis oncology chief executive officer Bruno Strigini said: Kisqali is emblematic of the innovation that Novartis...