Vertex Pharmaceuticals Incorporated today reported consolidated financial results for the quarter ended June 30, 2016 and reviewed recent progress with its approved and investigational cystic fibrosis medicines. "Just over a year ago, we received FDA approval for ORKAMBI, marking the most significant step to date in our journey to develop new medi
BioTelemetry, Inc., the leading wireless medical technology company focused on the delivery of health information to improve quality of life and reduce cost of care, is pleased to announce that it has received U.S. Food and Drug Administration 510 clearance of its next generation Mobile Cardiac Outpatient Telemetry? device, the MCOT? Patch.
GSK China`s Cervarix vaccine has been approved by the China Food and Drug Administration as the first human papillomavirus vaccine licensed for use in China. Cervarix is registered in China for use in girls and women aged 9-25 years with a three-dose schedule. A clinical trial conducted in China, involving more than 6,000 subjects who received Cerv
GeneOne Life Science, Inc. today announced the dosing of the first subjects in its multi-center Phase I trial to evaluate the Zika DNA vaccine. GeneOne has received approval from both the US FDA and Health Canada's Health Products and Food Branch to conduct the clinical trial for GLS-5700. The study will be conducted at clinical sites in Miami, Uni
Instrumentation Laboratory today announced the 510 clearance of the HemosIL HIT-Ab assay for use on ACL TOP Family Hemostasis Testing Systems, by the US Food and Drug Administration. The first, fully automated, on-demand assay for Heparin-Induced Thrombocytopenia on a Hemostasis testing system, HemosIL HIT-Ab detects antibodies associated with
The FDA had no major objections to LSKB's global phase 3 pivotal-trial study design for apatinib in patients with advanced gastric cancer. "We had a good, collaborative meeting with the U.S. FDA," said Dr. Sung Chul Kim, President of LSK BioPharma, "we received valuable guidance that we expect will help us to quickly bring apatinib to market and p
Progenics Pharmaceuticals, Inc. announced today that it has received a $50 million milestone payment from its worldwide collaboration partner, Valeant Pharmaceuticals International, Inc., resulting from the US Food and Drug Administration's marketing approval last week of RELISTOR Tablets for the treatment of opioid-induced constipation in...
AbbVie, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration has approved a New Drug Application for VIEKIRA XR? extended-release tablets. "AbbVie's work continues to contribute to the transformation of hepatitis C care through our focus on evolving our current therapies as part of our ongoing commitme
Enanta Pharmaceuticals, Inc.,, a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that the U.S. Food and Drug Administration has approved AbbVie s New Drug Application for VIEKIRA XR? extended release tablets. Our collaborative partner
Loop Industries, Inc., an environmentally responsible manufacturer of Purified Terephthalic Acid and Mono Ethylene Glycol, is pleased to announce that it has received a positive opinion letter from its FDA counsel confirming that the Company's proprietary depolymerization technology enables a tertiary recycling process which the FDA has concluded..
According to news originating from Katowice, Poland, by NewsRx correspondents, research stated, " Target- oriented drug discovery is the main research paradigm of contemporary drug discovery. Our news journalists obtained a quote from the research from the University of Silesia, "This can result in a higher molecular complexity, in particular, the
By a News Reporter-Staff News Editor at Pharma Business Week SinuSys Corporation, an innovative sinus health company, announced receipt of FDA clearance for a full family of sinus dilation devices, adding two new devices that will expand the company's portfolio of low-pressure, self-expanding dilation devices to enable dilation of the frontal and
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By a News Reporter-Staff News Editor at Heart Disease Weekly Abbott announced that the U.S. Food and Drug Administration has approved the company's Absorb bioresorbable heart stent, making the first-of-its-kind medical device commercially available to treat people with coronary artery disease in the United States. Absorb is the only fully dissolv