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 The leading web portal for pharmacy resources, news, education and careers July 24, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - July 24, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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7/22/17 - FDA approves drug to reduce risk of HER2-positive breast cancer returning [Arab Finance (Egypt)]
The US Food and Drug Administration has approved neratinib as the first extended adjuvant therapy for early-stage, HER2-positive breast cancer. Neratinib is a kinase inhibitor that works by blocking several enzymes that promote cell growth. Richard Pazdur, director of FDAs Oncology Center of Excellence and acting director of the Office of Hematolog
7/22/17 - FDA Clears First Neonatal Magnetic Resonance Imaging Device
The U.S. Department of Health and Human Services' Food and Drug Administration issued the following news release:. Today, the U.S. Food and Drug Administration cleared the first magnetic resonance imaging device specifically for neonatal brain and head imaging in neonatal intensive care units. "Although we can use traditional MRI scanners to image
7/22/17 - FDA clears first neonatal magnetic resonance imaging device [Syrian Arab News Agency]
Today, the US Food and Drug Administration cleared the first magnetic resonance imaging device specifically for neonatal brain and head imaging in neonatal intensive care units. Although we can use traditional MRI scanners to image neonates, taking babies outside of the neonatal intensive care unit to MRI suites presents great challenges, said Vasu
7/22/17 - GSK Receives FDA Approval for a New Self-Injectable Formulation of Benlysta (Belimumab) for Systemic Lupus Erythematosus
GlaxoSmithKline issued the following news release:. GSK announced today that the US Food and Drug Administration has approved a new subcutaneous formulation of Benlysta for the treatment of adult patients with active, autoantibody positive SLE who are receiving standard therapy. Systemic Lupus Erythematosus is the most common form of lupus, a ch
7/22/17 - MRI approved for young infants in intensive care [Sport360]
The first magnetic resonance imaging, or MRI, device designed to scan the heads and brains of newborns in intensive care units has been approved by the U.S. Food and Drug Administration. The Embrace Neonatal MRI System is the first unit approved to provide these scans of critically ill newborns, the FDA said Thursday in a news release. The system i
7/22/17 - NERLYNX (neratinib) Tablets Approved for HER2+ Breast Cancer in Extended Adjuvant Setting
McKesson issued the following news release:. Biologics, Inc., a McKesson Specialty Health oncology pharmacy services company, announced today it has been selected to be in the limited distribution network for Puma Biotechnology, Inc.' s new product, NERLYNX, a kinase inhibitor approved by the U.S. Food and Drug Administration. "We are pleased to b
7/22/17 - US FDA approves 1st neonatal MRI device [Philippines News Agency]
"Although we can use traditional MRI scanners to image neonates, taking babies outside of the neonatal intensive care unit to MRI suites presents great challenges," Vasum Peiris, chief medical officer for pediatrics and special populations at the FDA's Center for Devices and Radiological Health, said in a statement. The FDA explained that the new d
7/21/17 - Breckenridge Announces Final Approval for Omeprazole Delayed-Release Capsules
By a News Reporter-Staff News Editor at Drug Week Breckenridge Pharmaceutical, Inc. announced it has received U.S. Food and Drug Administration final approval of its abbreviated new drug application for Omeprazole delayed-release capsules, USP, in 10 mg, 20 mg, 40 mg strengths, which will be manufactured and supplied by its parent company, Labora
7/21/17 - FDA clears first neonatal magnetic resonance imaging device
Today, the U.S. Food and Drug Administration cleared the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU)...
7/21/17 - FDA Clears First Neonatal MRI Device
The FDA has cleared the first MRI device specifically for neonatal brain and head imaging in neonatal intensive care units. In fact, the Embrace neonatal MRI system, manufactured by Aspect Imaging Ltd., is designed specifically for imaging of the neonatal head.
7/21/17 - Gileads latest hep C combo approved in US [Sudan Tribune]
The FDA approved Vosevi, offering a single-tablet regimen for retreatment of adults with any of the six major hepatitis C genotypes who have previously received an NS5a inhibitor-containing regimen. Gilead is becoming a victim of its own success in hepatitis, as an increasing number of patients have been cured with its therapies and those from riva
7/21/17 - Gileads Vosevi receives FDA approval for re-treatment of chronic HCV [Arab Finance (Egypt)]
The US Food and Drug Administration has approved biotechnology company Gilead Sciences Vosevi tablets for the re-treatment of chronic hepatitis C virus infection. Gilead Sciences president and chief executive officer Dr John Milligan said: The evolution of Gileads portfolio of HCV single-tablet regimens has been driven by our commitment to address.
7/21/17 - GSK receives FDA approval for a new self-injectable formulation of Benlysta (belimumab) for systemic lupus erythematosus
GSK announced today that the US Food and Drug Administration has approved a new subcutaneous formulation of Benlysta for the treatment of adult patients with active, autoantibody-positive SLE who are receiving standard therapy. Systemic Lupus Erythematosus is the most common form of lupus, a chronic, incurable autoimmune disease producing...
7/21/17 - NERLYNX?(neratinib) Tablets Approved for HER2+ Breast Cancer in the Extended Adjuvant Setting
Biologics, Inc., a McKesson Specialty Health oncology pharmacy services company, announced today it has been selected to be in the limited distribution network for Puma Biotechnology, Inc. s new product, NERLYNX, a kinase inhibitor approved by the U.S. Food and Drug Administration. NERLYNX is indicated for the extended adjuvant treatment of adul
7/21/17 - SillaJen : China's FDA Oks To Commence Phase 3 Trial For Oncolytic Immunotherapy
HONG KONG- SillaJen, Inc. and Lee's Pharmaceutical Holdings Ltd. announced approval by the China Food and Drug Administration to conduct a Phase 3 clinical trial for advanced liver cancer using its oncolytic immunotherapy called Pexa-Vec, the PHOCUS study. SillaJen and Lee's Pharmaceutical participated in a first of its kind Chinese Center for Drug
7/21/17 - Summary: Senate Subcommittee Approves FY2018 Agriculture Appropriations Bill
Jeff Merkley, D- Ore., ranking Democratic member of the Senate Appropriations subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, issued the following news release:. The fiscal year 2018 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies bill provides a total discretion
7/21/17 - Teligent, Inc. Announces FDA Approval Of Erythromycin Topical Gel USP, 2%
Teligent, Inc., a New Jersey- based specialty generic pharmaceutical company, today announced it has received approval of the Company's abbreviated new drug application from the U.S. Food and Drug Administration of Erythromycin Topical Gel USP, 2%. "Erythromycin Topical Gel USP, 2% is Teligent's third FDA approval in 2017,'' commented Jason Gren
7/20/17 - Braeburn and Camurus Announce Submission of NDA for Long-Acting Buprenorphine (CAM2038) for Opioid Use Disorder
PRINCETON, N.J. and LUND, Sweden, July 20, 2017/ PRNewswire/ Braeburn Pharmaceuticals and Camurus today announced the completion of the rolling submission of a New Drug Application to the U.S. Food and Drug Administration for the approval of the companies' weekly and monthly buprenorphine depots to treat Opioid Use Disorder. Patients who do not t
7/20/17 - DarioHealth Receives U.S. FDA Clearance for Certain Leading Android Devices in the U.S.
Caesarea, Israel- July 20, 2017- DarioHealth Corp., a leading global digital health company with mobile health and big data solutions, today announced that the United States Food and Drug Administration has granted Pre-market Notification clearance for the Dario app on certain leading Android smart mobile devices. This news opens a significant U.S.
7/20/17 - FDA approves fixed-dose combination tablet for treating adults with chronic hepatitis C [Sport360]
The U.S. Food and Drug Administration today approved Vosevi to treat adults with chronic hepatitis C virus genotypes 1-6 without cirrhosis or with mild cirrhosis. Vosevi provides a treatment option for some patients who were not successfully treated with other HCV drugs in the past, "said Edward Cox, M.D., director of the Office of Antimicrobial Pr
7/20/17 - FDA Clears First Neonatal Magnetic Resonance Imaging Device
An MRImachine designed specifically for infants in the ICU has gotten the green light from the FDA.
7/20/17 - From Appropriations Vice Chair Patrick Leahy: SUMMARY Of The FY18 Agriculture Appropriations Bill, Approved TODAY By The Committee
COMMITTEE on APPROPRIATIONS VICE CHAIRMAN PATRICK LEAHY. WASHINGTON- The Senate Appropriations Committee Thursday approved the fiscal year 2018 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies bill that provides a total discretionary funding level of $20.525 billion, which is $352 million below the fiscal year 2017
7/20/17 - Merck Announces U.S. FDA Grants Tentative Approval for LUSDUNA? Nexvue? (insulin glargine injection), a Follow-On Biologic Basal Insulin
Merck, known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration has granted tentative approval for LUSDUNA? Nexvue? 100 units/mL, a follow-on biologic 1 basal insulin in a pre-filled dosing device. The trade name LUSDUNA Nexvue was granted provisional approval by the FDA and will be
7/20/17 - Merck:FDA Grants Tentative Approval For LUSDUNA Nexvue, Biologic Basal Insulin
KENILWORTH- Merck& Co. Inc. said that the U.S. Food and Drug Administration has granted tentative approval for LUSDUNA Nexvue or insulin glargine injection 100 units/mL, a follow-on biologic1 basal insulin in a pre-filled dosing device. Under the Hatch-Waxman Act, the initiation of Sanofi's lawsuit in September 2016 automatically invoked a stay on
7/20/17 - Peoria doctor's medical device proves successful [Journal Star, Peoria, Ill.]
July 19 PEORIA A Peoria doctor's medical invention has been used successfully for the first six times in Peoria and Tampa, Fla.. Bob Smouse, an interventional radiologist, received FDA approval last year for the ConvertX, a device that will simplify the way patients with blocked ureters are treated. The device has been used twice so far, three
Articles(s): 1 - 25 of 55     Next >>     Go To Page:


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