Hakusan, Japan- EIZO Corporation announced that it has received FDA 510 clearance for breast tomosynthesis from the U.S. Food and Drug Administration for its 8 megapixel multi-modality monitor, the RadiForce RX850. With FDA 510 clearance for the RadiForce RX850 in tomosynthesis, mammography, and general radiography, EIZO continues to provide a high
Toronto, Ontario- Theralase Technologies Inc., a leading biotechnology manufacturer focused on commercializing medical technologies to eliminate pain and destroy cancer, announced today that the Food and Drug Administration has granted 510 approval for Theralase s next generation therapeutic laser, the TLC -2000 Therapeutic Medical Laser System.
BASEL- The U.S. Food and Drug Administration approved Fluad, the first seasonal influenza vaccine containing an adjuvant. Fluad was first approved for use in Italy in 1997 and is currently approved in 38 countries, including Canada and 15 European countries. Fluad and Agriflu are manufactured by Novartis Vaccines and Diagnostics Limited, an affilia
INDIANAPOLIS- Eli Lilly and Co. announced that the U.S. Food and Drug Administration has approved Portrazza, in combination with gemcitabine and cisplatin, as the first biologic for the first-line treatment of people with metastatic squamous non-small cell lung cancer or NSCLC. Portrazza has been granted Orphan Drug Designation by the FDA.
By a News Reporter-Staff News Editor at Biotech Week Mallinckrodt plc, a leading specialty biopharmaceutical company, announced that the U.S. Food and Drug Administration has cleared INOmax DS Plus MRI device for delivery of INOMAX for inhalation during MRI procedures. Stephen Welty, Professor of Pediatrics and leading neonatologist.
This is the first time an animal with scientifically modified DNA has been approved by the FDA. As a leading provider of business intelligence, MarketResearch.com is pleased to offer insights into what this means for the food industry. In this particular case, FDA approval comes with a condition that the salmon only be raised in two specific land-b
By a News Reporter-Staff News Editor at Biotech Week Roche announced that the U.S. Food and Drug Administration has approved the cobas EGFR Mutation Test v2 for companion diagnostic use. The next-generation test from Roche includes expanded mutation coverage of the epidermal growth factor receptor gene in DNA derived from tumor tissue.
"While it's important to vaccinate people against the flu throughout their lives, the FDA approval of Fluad offers healthcare providers and their patients 65 years of age and older, who are at high risk for serious complications, a new option to help protect against influenza," said Gordon Naylor, President of Seqirus. According to the Centers for
By a News Reporter-Staff News Editor at Biotech Week Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration has approved Harvoni for expanded use in patients with genotype 4, 5 and 6 chronic hepatitis C virus infection and in patients co-infected with HIV. Harvoni received regulatory approval for the treatment of chronic HC
The U.S. Food and Drug Administration stated that it authorized another drug to treat a type of blood cancer called multiple myeloma. The approved drug, called Ninlaro, is made by Japanese drug company Takeda Pharmaceutical Co. The FDA sanctioned that two other multiple myeloma treatments this year, one from Johnson& Johnson and the other from Nova
NEW YORK CITY- Bristol-Myers Squibb Co.' s cancer drug Opdivo has received FDA approval for yet another indication- this time for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. The approval comes much ahead of projected FDA action date of March 16, 2016. Opdivo was first approved for th
Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration has approved Opdivo injection, for intravenous use, as a single agent for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. "Our focused approach to Immuno-Oncology research is to deliver treatment options that have the pot
Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration has approved Opdivo injection, for intravenous use, for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. 1 Today s announcement marks the approval of the first and only PD-1 inhibitor to deliver sig
-Entellus Medical, Inc., a medical technology company focused on delivering superior patient and physician experiences through products designed for the minimally invasive treatment of chronic and recurrent sinusitis patients, today announced the Company has received 510 clearance from the United States Food and Drug Administration for use of its..
U.S. regulators have approved the Bristol-Myers Squibb drug Opdivo for an advanced form of skin cancer, a day after the treatment also received backing to fight kidney cancer. The New York company said Tuesday that the Food and Drug Administration approved the injectable treatment for patients with a form of metastatic melanoma, which occurs whe
BASEL- The U.S. Food and Drug Administration approved Opdivo or nivolumab to treat patients with advanced or metastatic renal cell carcinoma, a form of kidney cancer, who have received a certain type of prior therapy. Opdivo is marketed by Bristol-Myers Squibb based in Princeton, New Jersey. Torisel is marketed by Pfizer, based in New York, New Yor
Emergent BioSolutions Inc. today announced that the U.S. Food and Drug Administration approved its supplemental Biologics License Application to expand the label of BioThrax to include post-exposure prophylaxis of disease following suspected or confirmed Bacillus anthracis exposure when administered in conjunction with recommended...
FDA approves first seasonal influenza vaccine containing an adjuvant. The U.S. Food and Drug Administration today approved Fluad, the first seasonal influenza vaccine containing an adjuvant. "Fluad provides another alternative for a safe and effective influenza vaccine in people 65 years of age and older," said Karen Midthun, M.D., director of the
INDIANAPOLIS, Nov. 24, 2015/ PRNewswire/ Eli Lilly and Company announced today that the U.S. Food and Drug Administration has approved Portrazza?, in combination with gemcitabine and cisplatin, as the first biologic for the first-line treatment of people with metastatic squamous non-small cell lung cancer. Portrazza has been granted Orphan Drug
HAYWARD, Calif., No. 24, 2015/ PRNewswire/ Impax Laboratories, Inc. today announced that on November 20, the Company's development and manufacturing partner received final approval by the U.S. Food and Drug Administration for a generic version of dutasteride capsules, 0.5 mg. This is the 13 th generic product launched in 2015 by Impax's generic d
Takeda Pharmaceutical Company Limited today announced that the U.S. Food and Drug Administration has approved NINLARO capsules, the first and only oral proteasome inhibitor, indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.