"The FDA approval of NATRELLE INSPIRA round gel-filled implants exemplifies our commitment to scientific innovation and to meeting the dynamic needs of plastic surgeons and their patients," said Scott Whitcup, M.D., Executive Vice President, Research and Development, Chief Scientific Officer, Allergan. "In the past two years, Allergan has received
By a News Reporter-Staff News Editor at Biotech Week Eisai Inc. announced that the U.S. Food and Drug Administration approved the company's receptor tyrosine kinase inhibitor LENVIMA? for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. LENVIMA was approved following a..
Bristol-Myers Squibb Company reported that the U.S. Food and Drug Administration has accepted for filing and review the Biologics Licensing Application for Opdivo for the treatment of patients with advanced squamous non-small cell lung cancer after prior therapy. "With the acceptance of our application for Opdivo in the squamous non-small cell lun
Irish pharmaceutical firm Actavis and Medicines360 have received approval from the US Food and Drug Administration for Liletta 52 mg for use by women to prevent pregnancy for up to three years. The partnership between the firms will allow women, regardless of income and insurance coverage, to access this new and effective contraceptive option.
Through our acquisition of Oncogenerix, Inc., which occurred on January 17, 2012, we acquired exclusive U.S. marketing rights to our first commercial FDA- approved proprietary product license, Soltamox? oral solution. Soltamox has been approved by the U.S. Food and Drug Administration for the prevention and treatment of breast cancer. On September
Thanks to the novel and innovative methods used during the study, Sirion received FDA approval of Difluprednate. Electronic source made the most practical and economic sense; however in researching the topic, we discovered a lack of FDA guidance, an absence of industry case studies, and no subject matter expertise such as consultants with experi
Cytori Therapeutics received approval from FDA to expand the number of Scleroderma clinical trial sites from 12 to 20 centers in the United States. According to a company release, the STAR study is an 80 patient pivotal clinical trial approved by FDA in January 2015 to study the effects of Cytori's lead drug ECCS-50 for treatment of patients with h
By a News Reporter-Staff News Editor at Cancer Weekly Biologics, Inc. an integrated oncology services company, is pleased to announce that Eisai Inc. has selected Biologics to be a specialty pharmacy provider within its limited distribution network for Lenvima?. Lenvima was approved by the U.S. Food and Drug Administration on February 13, 2015
We are also an established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the United States and abroad. In January 2015, we received FDA approval to market Triferic? our lead branded drug. We also received FDA approval to manufacture Calcitriol an injectable generi
Our first product, lomitapide, received marketing approval, under the brand name JUXTAPID capsules, from the U.S. Food and Drug Administration in late December 2012, as an adjunct to a low-fat diet and other lipid-lowering treatments, including low-density lipoprotein apheresis where available, to reduce low-density lipoprotein cholesterol, tota
BD, a leading global medical technology company, today announced the acquisition of CRISI Medical Systems, a San Diego- based medical technology company dedicated to improving the safety and delivery of IV injectable medications. The Intelliport system received clearance from the U.S. Food and Drug Administration in December 2014 and is expected
CorMatrix Cardiovascular Inc., a leading developer of biomaterials and medical devices, today announced FDA approval of an Investigational Device Exemption for an Early Feasibility Study of its CorMatrix ECM Tricuspid Heart Valve. Andrew Green, Executive Vice President of Operations, commented that The approval of the CorMatrix ECM Tricusp
Pacira Pharmaceuticals, Inc. today announced the receipt of a Complete Response Letter from the U.S. Food and Drug Administration following a review of its supplemental New Drug Application for the use of EXPAREL in nerve block to provide postsurgical analgesia. Pacira will immediately schedule an End-of-Review meeting with the Division of Anest
By a News Reporter-Staff News Editor at Pharma Business Week Seegene Inc., a leading developer of multiplex PCR technologies, announced that the U.S. Food and Drug Administration has granted 510 market clearance for its TOCE?- based herpes simplex virus types 1 and 2 assay. This is the first product that Seegene has taken through the FDA, and i
BASEL- Another month has come to a close, and here we bring you a list of new drugs that passed muster with the FDA in February. The drug is to be used in combination with letrozole, another FDA- approved product used to treat certain kinds of breast cancer in postmenopausal women. This drug is the first CDK 4/ 6 inhibitor to be approved by the FDA
WASHINGTON- Actavis plc, a global specialty pharmaceutical company, and Medicines360, a nonprofit women's health pharmaceutical company, today announced the approval of LILETTA by the U.S. Food and Drug Administration or FDA for use by women to prevent pregnancy for up to three years. Actavis and Medicines360's groundbreaking partnership would allo
Switzerland- based color and specialty chemicals company Archroma has received FDA approval for the use of its new Cartaguard KST additive in the manufacture of paper and board for food packaging. The product has been approved by the US Federal Food and Drug Administration under 21 CFR 176.170 and can be used as a grease resistance treatment before
Allergan, Inc. today announced that the company has received approval from the U.S. Food and Drug Administration to market NATRELLE INSPIRA? round gel-filled smooth breast implants. The FDA approval of NATRELLE INSPIRA? round gel-filled implants exemplifies our commitment to scientific innovation and to meeting the dynamic needs of plastic s
WASHINGTON- Allergan Inc. announced that it has received approval from the U.S. Food and Drug Administration or FDA to market Natrelle Inspira round gel-filled smooth breast implants. The FDA approval of Natrelle Inspira round gel-filled smooth breast implants marks the most recent addition to the broad portfolio of currently available Natrelle...
Immunovaccine Inc., a clinical stage vaccine and immunotherapy company, today announced that the U.S. Food and Drug Administration has approved its application for Fast Track designation and Phase I clinical trials of the DPX-Anthrax and DPX-Ebola vaccines, in conjunction with the mutual co-development agreement signed with Gilead Life Sciences.
The following discussion and analysis contains forward-looking statements about our plans and expectations of what may happen in the future. Our first product, AuryxiaTM, an oral, absorbable iron-based compound, received marketing approval from the U.S. Food and Drug Administration, or FDA, in September 2014 for the control of serum phosphorus leve
Priority Review is designated for drugs that the FDA believes have the potential to provide a significant improvement of a serious condition. "Eisai is dedicated to innovative science and patient care," said David Trexler, Senior Vice President, Eisai Oncology Business Unit, Eisai Inc. "We are pleased to introduce LENVIMA, a new treatment option t
Terry McAuliffe signed off on bills Thursday allowing people with severe epilepsy to use marijuana oils to treat seizures. The legislation came as welcome relief to Virginia Beach mom Tracie Thomas, whose son Caleb, 12, is in a clinical trial for just such a product. Paul Lyons, a Winchester neurologist, received clearance from the Food and Drug Ad
According to a Feb. 12, 2015 news release by Verastem, Inc., defactinib, a drug used to treat cancer by killing cancer stem cells, has received orphan drug designation from the U.S. Food and Drug Administration for use in the treatment of mesothelioma. "We are really excited about the FDA's decision," said Melinda Helbock, Founder of The Law Offic
-According to a Feb. 12, 2015 news release by Verastem, Inc., defactinib, a drug used to treat cancer by killing cancer stem cells, has received orphan drug designation from the U.S. Food and Drug Administration for use in the treatment of mesothelioma. We are really excited about the FDA's decision, said Melinda Helbock, Founder of The Law O