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 The leading web portal for pharmacy resources, news, education and careers June 27, 2016
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - June 27, 2016

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
Articles(s): 1 - 25 of 35     Next >>     Go To Page:

6/27/16 - FDA Approves the AspireAssist, a Minimally-Invasive Alternative to Weight Loss Surgery for People with Moderate to Severe Obesity
By a News Reporter-Staff News Editor at Pharma Business Week Aspire Bariatrics, Inc., announced that the US Food& Drug Administration has approved the AspireAssist System, an endoscopic alternative to weight loss surgery for people with moderate to severe obesity. AspireAssist therapy satisfies this need and additionally offers a lower cost so
6/25/16 - FDA Okays Trial for Medtronic's MRI-Guided Epilepsy Device [Daily Tribune (Bahrain)]
Medtronic plc MDT recently won the FDA's Investigational Device Exemption for the SLATE trial, which will evaluate this medical technology giant's Visualase MRI-Guided Laser Ablation technology. The SLATE study aims at enrolling 120 adult patients suffering from drug-resistant MTLE, who will be treated at selected epilepsy centers across the U.S. P
6/25/16 - T3D Therapeutics Receives FDA Approval for a 6-Month, Open-Label Extension to its Phase 2a Trial of T3D-959 for Treatment of Mild to Moderate... [Seven Days (United Arab Emirates)]
-T3D Therapeutics, Inc., a clinical stage drug development company targeting Alzheimers disease, is announcing that the U.S. Food and Drug Administration has granted approval for a 26- week, open-label extension to its 2- week Phase 2 a clinical trial of T3D-959 in a limited number of subjects who completed the main Phase 2 a study for the treatmen
6/24/16 - Endocure Technologies, Inc., A Wholly Owned Subsidiary Of MedServ Technologies, Inc., Has Received FDA 510k Clearance For The Manufacture Of Its New...
Endocure Technologies, Inc., A Wholly Owned Subsidiary Of MedServ Technologies, Inc., Has Received FDA 510 k Clearance For The Manufacture Of Its New Endocure Model EUR078A Urology Endoscope. By a News Reporter-Staff News Editor at Health& Medicine Week Endocure Technologies, Inc., our medical R&D and OEM company, has received FDA 510 clearance f
6/24/16 - Natco Pharma ends 4% higher; gets FDA nod for Glycopyrrolate Tablets [India Infoline News Service]
Natoco Pharma ended 3.8% higher after the company clarified to the BSE regarding USFDA approval the company received for generic version of Glycopyrrolate Tablets. "We received from our US agent on 22nd June 2016 intimating the approval for generic version of Glycopyrrolate Tablets 1 mg and 2 mg from US FDA. We have not disclosed the said news to a
6/24/16 - Unichem Lab closes 2% lower despite FDA nod for Alzheimer's drug [India Infoline News Service]
Shares of Unichem Laboratories ended 2.15% lower at Rs.266.25 on BSE despite the company announced that it has received ANDA approval from the United States Food and Drug Administration for Donepezil Hydrochloride Tablets USP. Donepezil Hydrochloride Tablets USP 5 mg and 10 mg are therapeutically equivalent to Aricept Tablets, 5 mg and 10 mg of Eis
6/23/16 - Allergan Announces FDA Approval of Supplemental New Drug Application (sNDA) for AVYCAZ (ceftazidime and avibactam)
Allergan plc, a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration has approved the company's supplemental New Drug Application to update the label for AVYCAZ with clinical data from a Phase 3 trial evaluating the safety and efficacy of AVYCAZ, in combination with metronidazole, for the treatment of co
6/23/16 - Centric Medical? Announces 510k Approval of Subtalar Arthroereisis Implant System for Foot and Ankle
Centric Medical, a division of Life Spine, Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology, announced today that the U.S. Food and Drug Administration has given 510 marketing clearance to the Subtalar Arthroereisis Implant System for treating hyperpronation of the foot and stabilization of the sub
6/23/16 - Incyte Gets FDA Approval For Breakthrough Therapy Status For Its Ruxolitinib
Incyte Corporation revealed Thursday that the Food and Drug Administration has granted Breakthrough Therapy Status for its ruxolitinib for the treatment of patients affected by acute graft-versus-host disease. Incyte' s Chief Medical Officer, Steven Stein, reacted, "Receiving Breakthrough Therapy Designation from the FDA recognizes the severe natur
6/23/16 - Natco Pharma gains on USFDA nod for generic Glycopyrrolate tablets [Tripoli Post, The (Libya)]
Natco Pharma was trading higher by 4% to Rs 552, extending its Wednesdays 6% rally on the BSE, after the company announced that it has received US Food and Drug Administration for generic version of Glycopyrrolate tablets. We received from our US agent on 22nd June 2016 intimating the approval for generic version of Glycopyrrolate Tablets 1 mg and
6/23/16 - T3D Therapeutics Receives FDA Approval for a 6-Month, Open-Label Extension to its Phase 2a Trial of T3D-959 for Treatment of Mild to Moderate Alzheimer's Disease
T3D Therapeutics, Inc., a clinical stage drug development company targeting Alzheimer's disease, is announcing that the U.S. Food and Drug Administration has granted approval for a 26- week, open-label extension to its 2- week Phase 2 a clinical trial of T3D-959 in a limited number of subjects who completed the main Phase 2 a study for the treatmen
6/23/16 - Transforming Cancer Treatment Paradigms Will Drive Record FDA Approvals - Research and Markets
Research and Markets has announced the addition of the "Key Pharma News Issue 53" report to their offering. 2015 FDA novel cancer drug approvals highlighted high innovation levels, but it was just an indication of the potential yet to be unlocked within the field. FDA novel approval rates will increase considerably with the purging of pipelines con
6/23/16 - U.S. FDA Approves Changes to the SABRIL (vigabatrin) REMS Program
Lundbeck today announced that the U.S. Food and Drug Administration approved a modified Risk Evaluation and Mitigation Strategy for Sabril . The Sabril REMS program, formerly known as SHARE, has been changed after the FDA determined that some of the program s requirements are no longer necessary to ensure that the benefits of Sabril outweigh t
6/22/16 - Key Pharma News Issue - Transforming Cancer Treatment Paradigms Will Drive Record FDA Approvals
Dublin- Research and Markets has announced the addition of the "Key Pharma News Issue 53" report to their offering. 2015 FDA novel cancer drug approvals highlighted high innovation levels, but it was just an indication of the potential yet to be unlocked within the field. FDA novel approval rates will increase considerably with the purging of pipel
6/22/16 - Key Pharma News Issue - Transforming Cancer Treatment Paradigms Will Drive Record FDA Approvals - Research and Markets
Research and Markets has announced the addition of the "Key Pharma News Issue 53" report to their offering. 2015 FDA novel cancer drug approvals highlighted high innovation levels, but it was just an indication of the potential yet to be unlocked within the field. FDA novel approval rates will increase considerably with the purging of pipelines con
6/22/16 - Opko Health Inc. (OPK) Stock Jumps on Rayaldee Approval [Jerusalem Post (Israel)]
Opko Health Inc. announced on Tuesday that the Food and Drug Administration has cleared Rayaldee, its treatment for secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease and vitamin D deficiency. Opko shares are up 7.4% in pre-market trading on the news. The biotech company has not been doing well since its billionaire fo
6/22/16 - OPKOs Rayaldee Product Receives FDA Approval - Uses Catalents OptiShell Capsule Technology as Delivery Platform [Emirates News Agency (WAM) (United Arab Emirates)]
-Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today welcomed OPKO Health, Inc.s announcement that its New Drug Application for Rayaldee has been approved by the US Food and Drug Administration. Catalent is pleased that Rayaldee i
6/21/16 - AiVita Biomedical Receives FDA Approval for Phase II Ovarian Cancer Treatment
AiVita Biomedical, a therapeutic development company focused on regenerative and curative medicines, today announced that the U.S. Food and Drug Administration has approved the Company's Investigational New Drug application to begin a Phase II clinical study. The study will investigate the efficacy of AiVita's novel immunotherapy in patients with
6/21/16 - ANDA Approvals Set To See Significant Increase In 2016 - Research and Markets
Research and Markets has announced the addition of the "World Generic Markets Issue 277" report to their offering. Aurobindo Gains FDA Tranexamic Acid Approval FDA Accepts Amgen's Biosimilar Adalimumab For Review Perrigo Completes Generic Tretinoin Portfolio Acquisition Amneal, Aurobindo Gain FDA Paricalcitol Approvals Granules Enters OTC...
6/21/16 - FDA Approves New Drug Application for RAYALDEE to Treat Secondary Hyperparathyroidism Associated with Vitamin D Insufficiency in Stage 3-4 Chronic Kidney Disease
OPKO Health, Inc. announced that the U.S. Food and Drug Administration has approved RAYALDEE extended release capsules for the treatment of secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease and serum total 25- hydroxyvitamin D levels less than 30 ng/mL. Phillip Frost, CEO and Chairman of OPKO. "RAYALDEE is the fir
6/21/16 - First Zika vaccine approved for human trials [Journal of Turkish Weekly, The]
An experimental vaccine for the Zika virus has been approved for human trials, the Food and Drug Administration said Monday. Created in a partnership between drug companies Inovio Pharmaceuticals and GeneOne Life Science, the vaccine, GLS-5700, showed promise when tested in small and large animals. The vaccine will be tested on approximately 40 pat
6/21/16 - First Zika vaccine will be tested on humans [Journal of Turkish Weekly, The]
An experimental vaccine for the Zika virus has been approved for human trials, the Food and Drug Administration said Monday An experimental vaccine for the Zika virus has been approved for human trials, the Food and Drug Administration said Monday. Created in a partnership between drug companies Inovio Pharmaceuticals and GeneOne Life Science, the
6/21/16 - OPKO's Rayaldee Product Receives FDA Approval - Uses Catalent's OptiShell? Capsule Technology as Delivery Platform
The new treatment uses Catalent's proprietary OptiShell? softgel capsule technology as its extended release delivery platform which allows for high-temperature encapsulation of semi-solid fill material within a non-gelatin, plant-based shell. Rayaldee Capsules will be manufactured at Catalent's North American Softgel Center of Excellence in St...
6/21/16 - PaizaBio: China Approves Drug Marketing Authorization Holder Pilot Plan, Green Lights Pharmaceutical Contract Manufacturing Sector [Global Data Point]
According to PaizaBio's David Deere, who oversees the company's aesptic fill/finish operations in China, this is significant as it approves the use of contract manufacturing organizations to produce drugs in China. The announcement is a clarification of policy reforms announced by China's Food and Drug Administration in late 2015 designed to accele
6/21/16 - Perrigo Announces FDA Clearance And Launch Of Non-GMO* Infant Formulas For The U.S. Store Brand Market
Perrigo Company plc, today announced it has received final U.S. Food and Drug Administration clearance for three milk-based, store brand non-GMO infant formulas. Perrigo introduced non-GMO formulas for consumers who prefer non-GMO versions of existing products. Perrigo's CEO, John T. Hendrickson stated, "We know that today's millennial mom is mor
Articles(s): 1 - 25 of 35     Next >>     Go To Page:


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