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 The leading web portal for pharmacy resources, news, education and careers July 31, 2015
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - July 31, 2015

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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7/28/15 - FDA Approves The ReShape? Integrated Dual Balloon System, A First-Of-Its-Kind Non-Surgical Weight Loss Procedure For People With Mild To Moderate Obesity
ReShape Medical today announced that the U.S. Food and Drug Administration has approved the ReShape? Integrated Dual Balloon System, a first-of-its-kind non-surgical weight loss procedure for people with mild to moderate obesity. The ReShape Procedure provides a new option for adults with a BMI of 30-40 and a related health condition who hav
7/28/15 - FibroGen Receives FDA Clearance to Proceed With Clinical Study of FG-3019 in Duchenne Muscular Dystrophy [Arab News (Saudi Arabia)]
-FibroGen, Inc., a research-based biopharmaceutical company, today announced that the U.S. Food and Drug Administration has completed its review of the Company's investigational new drug application for the study of FG-3019 in patients with Duchenne muscular dystrophy, and clinical study may proceed. The IND enables FibroGen to initiate a multi-sit
7/28/15 - First Aortic Valve Procedure With Newly Approved Device Performed at NYU Langone
NEW YORK, July 28, 2015/ PRNewswire-USNewswire/ NYU Langone Medical Center this week became the first academic medical center in the United States to implant a newly FDA- approved heart valve for transcatheter aortic valve replacement in patients with severe aortic stenosis. "We're excited to be the first center to use the new TAVR technology, w
7/28/15 - Kerastem Receives Conditional Approval from FDA for Alopecia Trial
The phase II study, known as the STYLE trial, follows initial clinical work in Europe and Japan. The data will be presented in September at the 2015 International Society of Hair Restoration Surgery meeting in Chicago. According to Principal Investigator Ken Washenik, MD, PhD, Medical Director Bosley Medical Group, and Clinical Assistant Professo
7/28/15 - MediciNova Announces FDA Approval of the Second Phase 2 Protocol for MN-001 in NASH Which Targets NASH Patients With Hypertriglyceridemia [Arab News (Saudi Arabia)]
-MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market and the JASDAQ Market of the Tokyo Stock Exchange, today announced that FDA has approved a second protocol for a clinical trial evaluating MN-001 for a NASH indication. This study targets NASH patients with hypertriglyceridemia to evaluate the ability of MN-001 to imp
7/28/15 - Nevro Announces Publication of SENZA-RCT Results in Anesthesiology
The Senza SCS system received FDA approval in May of 2015. The results of the SENZA-RCT, first presented at the North American Neuromodulation Society meeting in December of 2014, provided the evidentiary basis for HF10 therapy's superiority labeling from FDA, a first in the SCS space. Additional information, including 18- month data from the SE
7/27/15 - ANI Pharma, Sofgen Announce FDA Approval Of Nimodipine 30mg Capsules
WASHINGTON- ANI Pharmaceuticals, Inc. said its ANDA collaboration partner Sofgen has received approval from the U.S. Food and Drug Administration of the Abbreviated New Drug Application for Nimodipine 30 mg Capsules. Trailing twelve-month sales for the product are $25 million, according to IMS Health, with two current competitors.
7/27/15 - ANI Pharmaceuticals and Sofgen Announce FDA Approval of Nimodipine 30mg Capsules
ANI Pharmaceuticals, Inc. today announced that its ANDA collaboration partner Sofgen has received approval from the U.S. Food and Drug Administration of the Abbreviated New Drug Application for Nimodipine 30 mg Capsules. Arthur S. Przybyl, President and CEO of ANI Pharmaceuticals stated, "This represents ANI's first ANDA approval with our partner
7/27/15 - Europe approves Amgen's first-in-class cholesterol drug [Malta Independent, The]
Amgen on Tuesday received European approval for its first-of-a-kind cholesterol drug that lowers levels of the artery-clogging substance more than older drugs that have been prescribed for decades. The U.S. Food and Drug Administration is scheduled to make a decision on a similar drug from Sanofi and Regeneron Pharmaceuticals this Friday.
7/27/15 - FDA approves Novartis drug Odomzo (sonidegib) for locally advanced basal cell carcinoma (laBCC), a form of skin cancer
Release date- 24072015- Basel,- Novartis today announced the US Food and Drug Administration has approved Odomzo 200 mg capsules for the treatment of adult patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. 'The FDA approval
7/27/15 - FibroGen Receives FDA Clearance to Proceed With Clinical Study of FG-3019 in Duchenne Muscular Dystrophy
FibroGen, Inc., a research-based biopharmaceutical company, today announced that the U.S. Food and Drug Administration has completed its review of the Company's investigational new drug application for the study of FG-3019 in patients with Duchenne muscular dystrophy, and clinical study may proceed. The IND enables FibroGen to initiate a multi-si
7/27/15 - IRESSA gefitinib Approved by the U.S. Food and Drug Administration for First-Line Treatment of Advanced EGFR Mutation-Positive Non-Small Cell Lung...
By a News Reporter-Staff News Editor at Cancer Gene Therapy Week In the fifth paragraph and the second paragraph of the "Clinical Studies IPASS& IFUM" section of the release dated July 13, 2015, the last sentence should read: The Confidence Interval is 41, 59 and 61, 78. FOOD AND DRUG ADMINISTRATION FOR FIRST-LINE TREATMENT OF ADVANCED EGFR MUT
7/27/15 - Magellan Diagnostics Receives FDA Clearance for LeadCare Plus Clinical Lead Analyzer
By a News Reporter-Staff News Editor at Pharma Business Week Magellan Diagnostics, Inc., the leader in blood lead testing systems for both point-of-care and laboratory analysis, has received US Food and Drug Administration 510 clearance to market the LeadCare Plus Blood Lead Testing System in the US for the quantification of lead levels in blood.
7/27/15 - MediciNova Announces FDA Approval of the Second Phase 2 Protocol for MN-001 in NASH Which Targets NASH Patients With Hypertriglyceridemia
MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market and the JASDAQ Market of the Tokyo Stock Exchange, today announced that FDA has approved a second protocol for a clinical trial evaluating MN-001 for a NASH indication. This study targets NASH patients with hypertriglyceridemia to evaluate the ability of MN-001 to im
7/27/15 - Novo Nordisk Receives FDA Approval for FlexPro PenMate for People with Growth Hormone-Related Disorders
By a News Reporter-Staff News Editor at Pharma Business Week Novo Nordisk announced the U.S. Food and Drug Administration approval of FlexPro PenMate, designed for users of Norditropin FlexPro 5 mg, 10 mg, and 15 mg pens who dislike needles and prefer them to be hidden during the injection process. "Children and adolescents with growth hormone-r
7/27/15 - ONYX -FDA Approves Kyprolis (Carfilzomib) for Combination Use in the Treatment of Patients with Relapsed Multiple Myeloma
Release date- 24072015- Amgen today announced that the U.S. Food and Drug Administration approved the supplemental New Drug Application for Kyprolis for Injection in combination with Revlimid and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior lines of therapy. 'The expanded indication of Kypro
7/27/15 - St. Jude Medical Receives FDA Approval for the Industry's First Spinal Cord Stimulation Trial System to Incorporate Bluetooth Wireless Technology...
By a News Reporter-Staff News Editor at Pharma Business Week St. Jude Medical, Inc., a global medical device company, announced FDA approval of the St. The system, which received CE Mark in June 2015, is fully wireless and leverages Apple? technology for both the patient and physician controllers. With the Invisible Trial System, St. Jude Medic
7/27/15 - U.S. FDA Approves Otsuka and Lundbeck's REXULTI Brexpiprazole as Adjunctive Treatment for Adults with Major Depressive Disorder and as a Treatment...
By a News Reporter-Staff News Editor at Pharma Business Week Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S announced that the U.S. Food and Drug Administration approved REXULTI as an adjunctive therapy for the treatment of adults with major depressive disorder and as a treatment for adults with schizophrenia. REXULTI was discovered by Ot
7/27/15 - Upsher-Smith's ANDROXY? (Fluoxymesterone Tablets, USP) CIII Now Available
Upsher-Smith Laboratories, Inc. announced that it has received U.S. Food and Drug Administration approval of a supplemental abbreviated new drug application and request for an alternate active pharmaceutical ingredient manufacturer for ANDROXY? CIII. As the sole supplier of Fluoxymesterone Tablets in the U.S., Upsher-Smith made seeking this app
7/27/15 - Veloxis Announces U.S. FDA Approval of Envarsus XR for Treatment of Kidney Transplant Patients
By a News Reporter-Staff News Editor at Clinical Trials Week Veloxis Pharmaceuticals A/S announced U.S. Food and Drug Administration approval of Envarsus XR for the prophylaxis of rejection in kidney transplant patients who require or desire conversion from other twice-daily tacrolimus products to once-daily Envarsus XR. Veloxis expects Envarsus
7/26/15 - Novartis' new heart failure medicine LCZ696 approved by FDA to reduce risk of cardiovascular death and heart failure hospitalization; now called...
Novartis' new heart failure medicine LCZ696 approved by FDA to reduce risk of cardiovascular death and heart failure hospitalization; now called Entresto? sacubitril/valsartan. By a News Reporter-Staff News Editor at Medical Letter on the CDC& FDA Novartis announced that the US Food and Drug Administration has approved Entresto tablets, previou
7/26/15 - Protein Sciences Receives Approval from FDA for 2015/16 Formulation of Flublok Influenza Vaccine
By a News Reporter-Staff News Editor at Medical Letter on the CDC& FDA Protein Sciences Corporation announced that the FDA has approved the composition of Flublok influenza vaccine for the 2015/ 16 flu season. Every year, influenza vaccine manufacturers must receive approval from the FDA for changes they make to their vaccines so that the vaccine
7/26/15 - Switzerland : FDA approves Novartis drug Odomzo (sonidegib) for locally advanced basal cell carcinoma (laBCC), a form of skin cancer [TendersInfo (India)]
Novartis today announced the US Food and Drug Administration has approved Odomzo 200 mg capsules for the treatment of adult patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. "The FDA approval of Odomzo offers a new and..
7/26/15 - United States : FDA Approves Kyprolis (Carfilzomib) for Combination Use in the Treatment of Patients with Relapsed Multiple Myeloma [TendersInfo (India)]
Amgen today announced that the U.S. Food and Drug Administration approved the supplemental New Drug Application for Kyprolis for Injection in combination with Revlimid and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior lines of therapy. The expanded indication of Kyprolis provides patien
7/25/15 - Hospira: U.S. FDA OKs Launch of Generic Bivalirudin for Injection [Professional Services Close - Up]
Hospira reported it had obtained U.S. Food and Drug Administration approval for the launch of bivalirudin for injection, a generic version of The Medicines Company's Angiomax. Hospira said that its bivalirudin for injection is available in a single-dose flip-top vial, which matches the current branded offering available. "Hospira is excited to lau
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