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 The leading web portal for pharmacy resources, news, education and careers December 20, 2014
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - December 20, 2014

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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12/17/14 - ADVAXIS, INC. FILES (8-K) Disclosing Regulation FD Disclosure, Other Events
A copy of the press release of Advaxis, Inc. dated December 15, 2014 relating to the announcement discussed in Item 8.01 below is attached hereto as Exhibit 99.1. On December 15, 2014, the Company announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application to conduct a Phase 1/ 2 clinical study to evalu
12/17/14 - FDA approves first pathogen reduction system to treat plasma
ENP Newswire- 17 December 2014. Release date- 16122014- The U.S. Food and Drug Administration today approved the Intercept Blood System for plasma, the first pathogen reduction system for use by blood establishments in the preparation of plasma in order to reduce the risk of transfusion-transmitted infections. 'The approval of devices like the Inte
12/17/14 - FDA Approves Jakafi ruxolitinib for the Treatment of Patients with Uncontrolled Polycythemia Vera
By a News Reporter-Staff News Editor at Biotech Week PV is a myeloproliferative neoplasm and is typically characterized by elevated hematocrit, the volume percentage of red blood cells in whole blood, which can lead to a thickening of the blood and an increased risk of blood clots, as well as an elevated white blood cell and platelet count1.
12/17/14 - Ipsen Announces the FDA Approval of Somatuline Depot (lanreotide) Injection for the Treatment of Gastroenteropancreatic Neuroendocrine Tumors
Ipsen Biopharmaceuticals, Inc., an affiliate of Ipsen, today announced that Somatuline Depot Injection 120 mg was approved by the U.S. Food and Drug Administration for the treatment of gastroenteropancreatic neuroendocrine tumors in adult patients with unresectable, well or moderately differentiated, locally advanced or metastatic disease to.
12/17/14 - Quidel Gets FDA Clearance for AmpliVue Bordetella Assay [Health & Beauty Close - Up]
Quidel Corp. reported that it has received clearance from the United States Food and Drug Administration to market its AmpliVue Bordetella Assay for the detection of Bordetella pertussis nucleic acids isolated from nasopharyngeal swab specimens obtained from patients suspected of having a respiratory tract infection attributable to Bordetella...
12/17/14 - Quidel Receives Simultaneous FDA Clearance and CLIA Waiver for Its Sofia(R) Strep A+ Fluorescent Immunoassay (FIA) via the FDA's New Dual Submission Program
Quidel Corporation, a provider of rapid diagnostic testing solutions, cell-based virology assays and molecular diagnostic systems, announced today that it has received marketing clearance and CLIA waiver by the United States Food and Drug Administration for its Sofia Strep A+ Fluorescent Immunoassay for the rapid detection of infections by Group A.
12/17/14 - Strides Arcolab receives US FDA approval for Calcitriol Softgel Capsules; Product to be launched shortly
Release date- 16122014- Bangalore,: Strides Arcolab Limited today announced that it has received approval from the United States Food& Drug Administration for Calcitriol Softgel Capsules, 0.25 mcg and 0.5 mcg. The product will be manufactured at the Company's Oral dosage facility at Bangalore and marketed by Strides in the US Market. Strides Arcola
12/17/14 - TPI Expects To Receive GMP By End Of 2014; InVivo Reports FDA Approval to Expedite Enrollment for Pilot Trial
FDA for an expedited enrollment plan for the company s ongoing pilot trial of its investigational Neuro-Spinal Scaffold in patients with acute spinal cord injury. Under the new plan, barring significant safety issues, InVivo will submit two months of safety data to the FDA for the first subject enrolled in October, and will then open enrollment
12/17/14 - VASCAZEN POMEGA Phase IIa trial protocol cleared clinical evaluation by French FDA
-Pivotal Therapeutics Inc.,, a specialty pharmaceutical company with a focus on Omega-3 therapies for cardiovascular disease and overall health, announced that on December 16, 2014 the French FDA in Paris officially cleared the clinical evaluation part of the VASCAZEN POMEGA Phase IIa trial protocol. The VASCAZEN POMEGA Phase IIa clinical tri
12/17/14 - VASCAZEN POMEGA Phase IIa Trial Protocol Cleared Clinical Evaluation by French FDA
Pivotal Therapeutics Inc.,, a specialty pharmaceutical company with a focus on Omega-3 therapies for cardiovascular disease and overall health, announced that on December 16, 2014 the French FDA in Paris officially cleared the clinical evaluation part of the VASCAZEN POMEGA Phase IIa trial protocol. The VASCAZEN POMEGA Phase IIa clinical tria
12/16/14 - Bovie Medical Receives FDA 510(k) Approval for Bovie Ultimate? Generator
Bovie Medical Corporation, a maker of medical devices and supplies, and the developer of J-Plasma , a patented new surgical product, today announced that it has received FDA 510 approval for the Bovie Ultimate? generator. The Bovie Ultimate? is a high frequency electrosurgical generator that can be used for delivery of RF energy and/or helium
12/16/14 - BRIEF: FDA approves test to predict heart attack risk, especially in women [The Oregonian, Portland, Ore.]
The Food and Drug Administration approved the test for everyone, but company studies have shown it's especially effective for use on women, particularly black women. Heart disease is the leading cause of mortality in the United States for men and women, killing 600,000 people a year, according to the Centers for Disease Control and Prevention.
12/16/14 - Cepheid Receives FDA Clearance for Xpert Norovirus, the First On-Demand Molecular Test for Detection of Norovirus
By a News Reporter-Staff News Editor at Life Science Weekly Cepheid announced it has received clearance from the U.S. Food& Drug Administration to market Xpert Norovirus, a qualitative in vitro diagnostic test for expeditious identification and differentiation of Noroviruses genogroup I and genogroup II. All Xpert tests run on Cepheid's GeneXpert
12/16/14 - CVRx Granted Humanitarian Device Exemption Approval from FDA for Barostim neo legacy? Hypertension Therapy Device
CVRx, Inc., a privately held medical device company, announced today that it has received Humanitarian Device Exemption approval from the U.S. Food and Drug Administration for its Barostim neo legacy device. This milestone represents CVRx's first commercial approval in the United States and is based on a determination by the FDA that neo legacy i
12/16/14 - FDA OKs MP Biomedicals for HTLV Confirmatory Assay [Manufacturing Close - Up]
MP Biomedicals reported that it has received FDA approval on the MP Diagnostics HTLV Blot 2.4, a Western Blot for HTLV confirmatory testing and viral type discrimination. MP Biomedicals said the approval signifies the first ever FDA approved HTLV confirmatory assay in the U.S. MP Biomedicals continues to be focused on immunoblot confirmatory diagno
12/16/14 - FDA Approves INTERCEPT Blood System for Plasma
Cerus Corporation today announced that the U.S. Food and Drug Administration has approved the INTERCEPT Blood System for plasma. "Cerus 22 year commitment to improving transfusion safety has been essential to achieving the U.S. approval for INTERCEPT plasma, and our continued work with FDA on reaching an approval decision for the INTERCEPT Bloo
12/16/14 - FDA approves new blood test that predicts heart attack risk
The Food and Drug Administration has approved a blood test that purports to measure a person's risk of heart disease, cardiac arrest and the potential for other heart problems. The test, intended for those without evidence or history of heart disease, gauges a patient's risk by identifying a biomarker called Lp-PLA2, a signal of the vascular inflam
12/16/14 - FDA clears test that helps predict the risk of coronary heart disease
FDA cleared the test for use in all adults with no history of heart disease, but studies submitted by the company and reviewed by the FDA show that the test is better at discerning this risk in women, particularly black women. 'A cardiac test that helps better predict future CHD risk in women, and especially black women, may help health care profes
12/16/14 - FDA OKs WaterWear for MED-EL's Rondo [Health & Beauty Close - Up]
MED-EL USA received FDA approval for the WaterWear fully waterproof cover for the all-in-one Rondo Audio Processor. WaterWear will be available in early 2015. The announcement was made at the 14th Symposium on Cochlear Implants in Children in Nashville, Tenn.. Within seconds, this reusable accessory transforms the Rondo into a completely waterproof
12/16/14 - HedgePath Pharmaceuticals Receives IND Clearance to Commence Development of its Proposed Cancer Treatment
Nicholas J. Virca, HPPI's President and Chief Executive Officer, commented, "We are very gratified and proud to have achieved FDA clearance of our first IND, under which we will seek to repurpose SUBA-Itraconazole as a candidate for anti-cancer therapy in humans. The trial design cleared by FDA is a single arm, Phase IIb, multi-center, open-label,.
12/16/14 - iGrow Hair Growth System Receives FDA Over-the-Counter Clearance for Women
Apira Science, Inc. today announced the FDA has granted the company over-the-counter clearance for its iGrow Hair Growth System to effectively promote hair growth in women with Fitzpatrick skin phototypes I to IV and with Ludwig Baldness Scale Classifications of I to II. The hands-free, in-home hair growth device is now widely available without
12/16/14 - InVivo Reports FDA Approval to Expedite Enrollment for Ongoing Pilot Trial
Under the new plan, barring significant safety issues, InVivo will submit two months of safety data to the FDA for the first subject enrolled in October, and will then open enrollment for the second subject in mid-January. Upon enrollment of the second subject, InVivo will submit to the FDA one month of safety data for that subject together with th
12/16/14 - InVivo Therapeutics Announces FDA Approval to Expedite Enrollment for Ongoing Pilot Trial
InVivo Therapeutics Holdings Corp. today announced approval by the U.S. Food and Drug Administration for an expedited enrollment plan for the company s ongoing pilot trial of its investigational Neuro-Spinal Scaffold in patients with acute spinal cord injury. Under the new plan, barring significant safety issues, InVivo will submit two months of
12/16/14 - Ipsen Announces the FDA Approval of Somatuline Depot (lanreotide) Injection for the Treatment of Gastroenteropancreatic Neuroendocrine Tumors
Ipsen Biopharmaceuticals, Inc., an affiliate of Ipsen, today announced that Somatuline Depot Injection 120 mg was approved by the U.S. Food and Drug Administration for the treatment of gastroenteropancreatic neuroendocrine tumors in adult patients with unresectable, well or moderately differentiated, locally advanced or metastatic disease to.
12/16/14 - Ipsen's Somatuline Depot is the First Therapy Approved by the FDA in the United States for the Treatment of Patients with Locally Advanced or Metastatic Gastroenteropancreatic Neuroendocrine Tumors
Ipsen today announced that Somatuline Depot Injection 120 mg was approved by the U.S. Food and Drug Administration for the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors. Marc de Garidel, Chairman and Chief Executive Officer of Ipse
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