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 The leading web portal for pharmacy resources, news, education and careers February 15, 2019
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - February 15, 2019

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 34     Next >>     Go To Page:

2/15/19 - Bio-Rad Releases First FDA-Cleared Digital PCR System and Test for Monitoring Chronic Myeloid Leukemia Treatment Response
Bio-Rad Laboratories, Inc., a global leader of life science research and clinical diagnostic products, today announced that its QXDx AutoDG ddPCR System, which uses Bio-Rad s Droplet Digital PCR technology, and the QXDx BCR-ABL% IS Kit are the industry s first digital PCR products to receive U.S. Food and Drug Administration clearance. Used t
2/15/19 - Global Nanopharmaceuticals Market to Surpass US$ 168.91 Billion by 2026
According to Coherent Market Insights, the global nanopharmaceuticals market was valued at US$ 28,434.3 million in 2017, and is projected to exhibit a CAGR of 22.1% over the forecast period. For example, in August 2017, Jazz Pharmaceuticals received FDA approval for Vyxeos, used for the treatment of acute myeloid leukemia. For instance, in March 20
2/15/19 - Miph Stapler(Hemorrhoid Stapler Set for the Pr Ocedure for Hamorrhoids and Prolapse), Size 33 to 35 Mm,Us -Fda/Bis & Ce Approved
Address: Head Quarters Office, Loco Colony, Jaipur -302006, Rajasthan, Attn: Divisional Railway Manager.
2/15/19 - New Wave Endo-Surgery Inc. Completes the Acquisition of FDA Cleared Anesthesia Nerve Block Needle Product Line
New Wave Endo-Surgery Inc. announced today that it completed the acquisition of the Acacia Inc. FDA cleared Nerve Block Needle and anesthesia kit product line. New Wave Endo-Surgery Inc. was founded in 2014 to design, and manufacture proprietary medical devices for laparoscopic and robotic surgery. New Wave Endo-Surgery Inc. will be presenting thei
2/15/19 - Spravato gets FDA Advisory Committee approval [T-break Tech (Middle East)]
The US Food and Drug Administration Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee jointly voted in favour of Spravato nasal spray CIII for adults living with treatment-resistant depression. The decision came down to 14 yes votes, two no votes and one abstain, basing their support on the safety an
2/14/19 - Dicyclomine HCl Injection, USP- Now Available from Nexus Pharmaceuticals
Nexus Pharmaceuticals announced today it has received U.S. Food and Drug Administration approval for Dicyclomine Hydrochloride Injection, USP in 20 mg/2mL vial, the generic equivalent to Bentyl . Dicyclomine HCl, USP, is currently listed on the American Society of Health-System Pharmacists' drug shortage list. The addition of Dicyclomine Injec
2/14/19 - FDA Clears Next SIG Medical AdvantageRib System
SIG Medical announced today that the U.S. Food and Drug Administration has granted 510 clearance for its enhanced AdvantageRib System, K183317. The US full market launch is slated to occur at the 2019 Chest Wall Injury Society Annual Meeting where the leading experts gather to focus on operative care of patients with chest wall injures. SIG Medic
2/14/19 - Lipocine Inc. Announces FDA Clearance of IND to Commence Phase 2 Study of LPCN 1144 in Biopsy Confirmed NASH Subjects
Lipocine Inc., a specialty pharmaceutical company, today announced that the U.S. Food& Drug Administration indicated that the Phase 2 clinical study of LPCN 1144 in non-alcoholic steatohepatitis with biopsy confirmed NASH subjects may proceed in response to the Company's Investigational New Drug application. Lipocine's planned Phase 2 clinical st
2/14/19 - Mayne Pharma launches Lexette foam 0.05% in the United States
ADELAIDE- Mayne Pharma Group Limited is pleased to announce the launch of LEXETTE Foam 0.05% in the United States. LEXETTE received approval from the US Food and Drug Administration in May 2018 with three years of marketing exclusivity. Mayne Pharma directly markets more than 60 products in the US including four branded dermatology products FABIOR
2/14/19 - Medality Medical? LLC Receives FDA Investigational Device Exemption Approval for Reversal of Type 2 Diabetes Clinical Trial
Medality Medical LLC, a U.S.- based medical technology company, announced that it has received U.S. Food& Drug Administration Investigational Device Exemption approval to undertake a clinical trial of its patented proprietary medical device and surgical procedure designed to reverse type 2 diabetes and associated obesity. According to the American.
2/14/19 - Novartis Receives FDA Approval for Egaten for the Treatment of Fascioliasis, a Neglected Tropical Disease
Novartis issued the following news release:. -Egaten is the only drug approved in the US for the treatment of people with fascioliasis and is currently the only treatment recommended by the WHO. Novartis announced today that the US Food and Drug Administration has approved Egaten (R) for the treatment of fascioliasis in patients six years of age an
2/13/19 - Anti-venom Market New Trends and Current Industry Demand 2018- 2026 | Top Key Vendors BTG plc. Laboratorios Silanes, CSL Limited, Pfizer, Inc., Merck & Co., Inc.
Anti-venom Market was valued at US$ 504.9 Mn in 2018, and is projected to exhibit a CAGR of 4.7% during the forecast period. For instance, in October 2018, Silanes Laboratories received the U.S. Food and Drug Administration approval for its new anti-venom namely ANAVIP. In 2018, Rare Disease Therapeutics, Inc., a partner of Silanes Laboratories lau
2/13/19 - FDA Clears Safe Medical Design's Innovative New Urinary Catheter Design Aimed At Increased Patient Safety
Safe Medical Design, Inc., a medical device company dedicated to developing safe and cost-effective solutions in urology, today announced that the U.S. Food and Drug Administration cleared the Signal Catheter? for commercialization in the United States. This is a monumental shift in a field that has changed very little for the better part of 2
2/13/19 - Genmab Announces U.S. FDA Approval of DARZALEX (daratumumab) Split Dosing Regimen [Syrian Arab News Agency]
Genmab A/S announced today that the U.S. Food and Drug Administration has approved a split dosing regimen for DARZALEX. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab. We are pleased that, with this change, patients in the U.S. receiving their first infusion of DARZALEX ma
2/13/19 - Genmab Announces U.S. FDA Approval of DARZALEX Split Dosing Regimen
Genmab A/S announced today that the U.S. Food and Drug Administration has approved a split dosing regimen for DARZALEX. The supplemental Biologics License Application was submitted by Genmab's licensing partner, Janssen Biotech, Inc., in July, 2018. 'We are pleased that, with this change, patients in the U.S. receiving their first infusion of DARZA
2/13/19 - GNW-News: Novartis receives FDA approval for Egaten for the treatment of fascioliasis, a neglected tropical disease (english)
Novartis receives FDA approval for Egaten for the treatment of fascioliasis, a neglected tropical disease. Novartis International AG/ Novartis receives FDA approval for Egaten for the treatment of fascioliasis, a neglected tropical disease. Processed and transmitted by West Corporation.
2/13/19 - Janssen Pharmaceutical - U.S. FDA Approves DARZALEX Split-Dosing Regimen
Horsham- The Janssen Pharmaceutical Companies of Johnson& Johnson announced today that the U.S. Food and Drug Administration has approved a split-dosing regimen for DARZALEX, providing healthcare professionals and patients with multiple myeloma an option to split the first infusion over two consecutive days. The U.S. FDA approval is based on data f
2/13/19 - Lupin launches Tadalafil Tablets USP
Mumbai- Pharma major Lupin announced the launch of Tadalafil Tablets USP 20 mg, having received an approval from the United States Food and Drug Administration earlier. For the financial year ended 31st March, 2018, Lupin's Consolidated sales and Net profits before exceptional items were at Rs. 155,598 million and Rs. 13,934 million respectively.
2/13/19 - Lupin receives FDA approval for Fluoxetine Tablets USP
Mumbai- Pharma major Lupin announced that it has received approval for its Fluoxetine Tablets USP, 60 mg, from the United States Food and Drug Administration to market a generic version of Alvogen's Fluoxetine Tablets, 60 mg. Lupin's Fluoxetine Tablets USP, 60 mg, is the generic version of Alvogen's Fluoxetine Tablets, 60 mg. It is indicated in the
2/13/19 - Novartis Receives FDA Approval for Egaten for the Treatment of Fascioliasis, a Neglected Tropical Disease
Egaten is the only drug approved in the US for the treatment of people with fascioliasis and is currently the only treatment recommended by the WHO Fascioliasis, commonly known as liver fluke, is estimated to infect 2.4 million people globally 1 Novartis has been donating Egaten to the WHO since 2005, helping to treat around 2 million patients in m
2/13/19 - U.S. FDA Approves DARZALEX (Daratumumab) Split-Dosing Regimen
Janssen Pharmaceutical Companies, a subsidiary of Johnson and Johnson, issued the following news release:. The Janssen Pharmaceutical Companies of Johnson& Johnson announced today that the U.S. Food and Drug Administration has approved a split-dosing regimen for DARZALEX, providing healthcare professionals and patients with multiple myeloma an opti
2/12/19 - Award-Winning, FDA-Cleared Technology Uses Body's Own Fat to Help Heal Orthopedic Injuries
A nationally recognized Louisiana orthopedic surgeon is now offering an exciting, FDA- cleared medical technology that delivers an ingenious new use for ordinary body fat. The system, called Lipogems, actually unlocks fat's natural ability to support healing of injured or damaged tissues. Kevin Darr of Covington Orthopedic& Sports Medicine Instit
2/12/19 - Biomet Receives FDA Clearance for ROSA One Brain Application
Zimmer Biomet has received U.S. Food and Drug Administration clearance for the ROSA One Brain Application, a robotic surgical navigation and positioning system for use in neurosurgical procedures. Having a single robot able to perform both brain and spine surgery will significantly advance Zimmer Biomet's position in the robotic surgical space.
2/12/19 - FDA Advisory Committee Recommends Approval of SPRAVATO? (esketamine) Nasal Spray CIII for Adults with Treatment-Resistant Depression
The Janssen Pharmaceutical Companies of Johnson& Johnson today announced that the U.S. Food and Drug Administration Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee jointly voted that data support the favorable benefit-risk profile of SPRAVATO TM nasal spray CIII for adults living with...
2/12/19 - Genmab Announces U.S. FDA Approval of DARZALEX (daratumumab) Split Dosing Regimen
Genmab A/S announced today that the U.S. Food and Drug Administration has approved a split dosing regimen for DARZALEX . The approval will be included in an update to the Prescribing Information in order to provide healthcare professionals the option to split the first infusion of DARZALEX over two consecutive days. In August 2012, Genmab granted
Articles(s): 1 - 25 of 34     Next >>     Go To Page:


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