Akashi Therapeutics, Inc. a clinical stage biopharmaceutical company developing treatments for patients with Duchenne muscular dystrophy, today reported that the U.S. Food and Drug Administration has completed its review and concluded that Akashi may resume clinical development of HT-100 in patients with any of the genetic mutations that cause DMD,
By a News Reporter-Staff News Editor at Computer Weekly News- Beckman Coulter Diagnostics announces FDA clearance and U.S. commercial launch of its new DxC 700 AU chemistry analyzer. "In today's changing healthcare climate, laboratories are asked to elevate care and to reduce costs," said John Blackwood, senior vice president of chemistry and im
BioStable Science& Engineering, Inc. announced today it has received FDA market clearance for the HAART 300 Aortic Annuloplasty Device, the first commercially available internal annuloplasty device designed for aortic valve repair. They have demonstrated how our technologies help to simplify and standardize aortic valve repair, and I am excited to
Gone was the requirement that foreign drugmakers can only apply to start clinical trials for a drugexcept for vaccinesin China after it has at least entered phase 2 testing elsewhere. Perhaps more dramatically, the new rules would allow foreign drugmakers to file for a new drug approval using data from international, multicenter trials, so long as
Release date- 21032017- The U.S. Food and Drug Administration today approved Xadago tablets as an add-on treatment for patients with Parkinson's disease who are currently taking levodopa/carbidopa and experiencing' off' episodes. 'Parkinson's is a relentless disease without a cure,' said Eric Bastings, M.D., deputy director of the Division of Neuro
The U.S. Food and Drug Administration announced today it has approved a new drug, Xadago, for the treatment of Parkinson's disease. Roughly 50,000 Americans are diagnosed with Parkinson's disease each year and about 1 million people have have it, according to the National Institutes of Health. Eric Bastings, deputy director of the Division of Neuro
Eric Bastings said in an FDA news release. "We are committed to helping make additional treatments for Parkinson's disease available to patients," added Bastings, deputy director of neurology products in the FDA's Center for Drug Evaluation and Research. The FDA's approval of the drug is based on two clinical trials.
Medtronic issued the following news release:. Medtronic plc today announced U.S. Food and Drug Administration approval and U.S. launch of the CoreValve (TM) Evolut (TM) PRO valve for the treatment of severe aortic stenosis for symptomatic patients who are at high or extreme risk for open heart surgery. "Based on my experience implanting the Evolut
First-Ever Data at ACC.17 Confirms Safety and Efficacy of New Self-Expanding, Recapturable Heart Valve at 30- Days with High Survival, Low Stroke and Minimal Paravalvular Leak DUBLIN- March 22, 2017- Medtronic plc today announced U.S. Food and Drug Administration approval and U.S. launch of the CoreValve Evolut PRO valve for the treatment of severe
Some 50,000 Americans are diagnosed each year with Parkinson's, and about 1 million Americans have the neurological condition, the FDA said, citing the U.S. National Institutes of Health. The absence of enough dopamine leads to lack of smooth, purposeful movement during activities such as walking, eating, writing or shaving, the FDA said. Certain p
Revenio Group Corporation, Stock Exchange Release March 22, 2017, at 09.30 FDA MARKETING APPROVAL GRANTED TO ICARE HOME TONOMETER IN THE UNITED STATES Revenio Group's subsidiary, Icare Finland Oy has received a marketing approval for the Icare HOME tonometer in the United States. Being granted a marketing approval in the United States represents a
In the future multinationals may no longer be required to have their drugs licensed or have completed the second or third phase of clinical trials on new drugs in their country of origin before they can begin tests in China, according to a draft document released by the China Food and Drug Administration on Friday. Manufacturers of imported drugs w
"We are very pleased to have achieved clarity from FDA regarding Esperions LDL-C lowering development program," saidTim M. Mayleben, president and chief executive officer of Esperion. Interactions with FDA also addressed the ongoing cardiovascular outcomes trial, Cholesterol Lowering via BEmpedoic Acid, an ACL-inhibiting Regimen Outcomes for bemped
The U.S. Department of Health and Human Services' Food and Drug Administration issued the following news release:. The U.S. Food and Drug Administration today approved Xadago tablets as an add-on treatment for patients with Parkinson's disease who are currently taking levodopa/carbidopa and experiencing "off" episodes. "Parkinson's is a relentless
Milan, Italy and Morristown, NJ, U.S.A.,- March 21, 2017- Newron Pharmaceuticals S.p.A., a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system and pain, and its partners Zambon S.p.A. and US WorldMeds, LLC, announced today that the Food and Drug Administration has approved
FDA has cleared the ARTIS pheno, a robotic C-arm angiography system from Siemens Healthineers created for use in minimally invasive interventional procedures. The system possesses a zen40HDR flat panel detector, GIGALIX X-ray tube, but and new 2k recording technology.
Release date- 18032017- CARY, N.C.- 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
NORTH CHICAGO- It's been a little over eight months since Abbott Vascular Inc.' s, a division of Abbott Labs, fully absorbable stent, Absorb GT1 Bioresorbable Vascular Scaffold, received FDA approval. The FDA, which reviewed a two-year data from Abbot's pivotal clinical study evaluating the safety and effectiveness of the stent, dubbed ABSORB III,
WASHINGTON- Allergan plc. said that it has received approval from the U.S. Food and Drug Administration to market JUV?DERM VOLLURE XC, for correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults over the age of 21. JUV?DERM VOLLURE XC was first approved in Europe as JUV?DERM VOLIFT in 2013. The JUV?DERM f
THOUSAND OAKS- Amgen Inc. on Friday reported positive results from its Repatha cardiovascular outcomes study, dubbed FOURIER. The company's cholesterol drug Repatha received FDA approval on August 27, 2015. Terming the results as a game changer, Sean Harper, executive vice president of Research and Development at Amgen, said, "Even though high-risk
"We are very pleased to have achieved clarity from FDA regarding Esperion s LDL-C lowering development program," said Tim M. Mayleben, president and chief executive officer of Esperion. Interactions with FDA also addressed the ongoing cardiovascular outcomes trial, C holesterol L owering via B E mpedoic Acid, an A CL-inhibiting R egimen Outcomes
LGC Maine Standards is pleased to announce its VALIDATE HEPARIN calibration verification/ linearity test kit has received US FDA 510 clearance for use on Instrumentation Laboratory ACL TOP 500 hemostasis test systems. LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE calibration verification/ linearity
Release date- 18032017- Mumbai, Baltimore- Pharma Major Lupin Limited announced today the launch of Mibelas 24 Fe having received an approval from the United States Food and Drug Administration earlier. Lupin's Mibelas 24 Fe is the AB rated generic equivalent of Allergan Pharmaceuticals International Limited's Minastrin 24 Fe Tablets.
HERTFORDSHIRE, England and PITTSBURGH, March 20, 2017/ PRNewswire/ Mylan N.V., a leading global pharmaceutical company, today announced receipt of tentative approval from the U.S. Food and Drug Administration under the U.S. President's Emergency Plan for AIDS Relief for its New Drug Application for Efavirenz, Lamivudine and Tenofovir Disoproxil F