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 The leading web portal for pharmacy resources, news, education and careers January 21, 2019
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - January 21, 2019

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 38     Next >>     Go To Page:

1/20/19 - Alphabet's health division gets clearance for on-demand ECG feature in smartwatch [New Indian Express (India)]
CALIFORNIA: After Apple, Google' s parent company Alphabet is working its way towards bringing health at the center of its products. Now, the company's health division Verily has reportedly received FDA 510 clearance for its Study smartwatch for an on-demand ECG feature. The Study Watch, announced two years ago, is intended to be a test platform fo
1/20/19 - US FDA Approves ONTRUZANT (trastuzumab-dttb), Samsung Bioepis First Oncology Medicine in the United States
INCHEON, Korea Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration has approved ONTRUZANT , a biosimilar referencing HERCEPTIN 1, across all eligible indications, namely adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophageal juncti
1/19/19 - AIVITA gets IND nod for Phase 1B melanoma trial [Syrian Arab News Agency]
AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for a Phase 1 B clinical trial investigating the Company`s ROOT OF CANCER technology in patients with metastatic melanoma. AIVITA`s ROOT OF CANCER...
1/19/19 - Alphabet's health division gets clearance for on-demand ECG feature in smartwatch [Asian News International]
California, January 19: After Apple, Google' s parent company Alphabet is working its way towards bringing health at the center of its products. Now, the company's health division Verily has reportedly received FDA 510 clearance for its Study smartwatch for an on-demand ECG feature. The feature is increasingly becoming a standard for a lot of manuf
1/19/19 - US FDA focuses on generics and approves first for Sabril [Syrian Arab News Agency]
The FDA approved Teva`s generic for Sabril, the first generic for the drug, as the agency continues to focus its efforts to approve generics that face little competition. The US Food and Drug Administration has expressed its efforts to carve a path for generic drug development, even in the case of limited distribution programs for brand name drugs,
1/18/19 - AbbVie Provides Update on Phase 3 Study of Ibrutinib (IMBRUVICA) in Metastatic Pancreatic Cancer
AbbVie, a research-based global biopharmaceutical company, today announced an update on the Phase 3 RESOLVE trial of ibrutinib in combination with chemotherapy agents nab-paclitaxel and gemcitabine versus placebo in combination with these chemotherapy agents in patients with metastatic pancreatic adenocarcinoma. IMBRUVICA is a first-in-class...
1/18/19 - AIVITA Biomedical Receives IND Clearance for Phase 1B Melanoma Trial [Sudan Tribune]
AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, announced today the U.S. Food and Drug Administration has cleared its Investigational New Drug application for a Phase 1 B clinical trial investigating the Company`s ROOT OF CANCER technology in patients with metastatic melanoma. The trial marks the first
1/18/19 - FDA Approves Potential Lifesaver For Thousands Of Premature Babies [Syrian Arab News Agency]
The Food and Drug Administration has just approved an amazing new device that could be a lifesaver for thousands of premature babies. The little umbrella-like device closes an abnormal blood vessel. Aimee Armstrong of the Nationwide Childrens Hospital.
1/18/19 - FDA Clears Integrated System from Ortho Clinical Diagnostics
The Vitros 7600 and its Digital Chemistry technology represent an innovative approach to clinical lab management, enabling powerful data intelligence, operational improvements, and other enhancements in the lab.
1/18/19 - Genexine, NeoImmuneTech wins FDA nod for clinical trials of GX-I7 [T-break Tech (Middle East)]
Genexine and NeoImmuneTech have received approval from the U.S. Food and Drug Administration to conduct the clinical trials of a combination treatment between GX-I7, an immunotherapeutic drug candidate, and Roches Tecentriq, in treating high-risk skin cancer. The two companies will start phase 1 b and 2 a clinical trials of the combination treatmen
1/17/19 - Award-Winning, FDA-Cleared Technology Uses Body's Own Fat to Help Heal Orthopedic Injuries
CEDAR KNOLLS, N.J., Jan. 17, 2019/ PRNewswire/ LIPOGEMS is an award winning technology and received the 2016 award for Best New Technology in Sports Medicine from the influential medical publication Orthopedics This Week. LIPOGEMS continues to surge in popularity, especially among patients seeking another option to major, invasive surgery, with t
1/17/19 - Crohn's Disease Treatment Market Industry Review, Key Players Profile, Statistics and Growth to 2026
North America and Europe to dominate Crohn's disease treatment market owing to high incidence and prevalence of the disease. According to a study published in the Lancet in October, 2017, around 319 and 322 cases of Crohn's disease per 1, 00,000 people were reported in the U.S. and Europe respectively. For instance, in 2017, the U.S. FDA granted ap
1/17/19 - EBM Technologies Announces Industry Breakthrough with First FDA Cleared System for Remote Diagnostic Reading of Radiological Images
Vendor Neutral, iPad Pro-based Rad@ System Untethers Radiologists from Fixed Workstations, Paving Way for Greater Work Flexibility and Financial Efficiencies. TAIPEI& CHICAGO EBM Technologies today announced that its vendor neutral, remote reading system Rad@ has been granted Class II FDA clearance for diagnostic reading of radiological images.
1/17/19 - FDA Approves First Generic Version Of Epilepsy Drug Sabril
PETAH TIKVA- The U.S. Food and Drug Administration has approved the first generic version of Sabril for treatment of complex partial seizures. The generic version of Sabril is manufactured by Teva Pharmaceutical Industries. The availability of high-quality generic alternatives of critically important medicines, once the period of patent protection
1/17/19 - FDA approves first generic version of Sabril to help treat seizures in adults and pediatric patients with epilepsy
The U.S. Food and Drug Administration approved the first generic version of Sabril 500 mg tablets for treating complex partial seizures, also called focal seizures, as an adjunctive therapy in patients 10 years and older who have responded inadequately to several alternative treatments. 'Prioritizing the approval of generic drugs to compete with me
1/17/19 - FDA approves scalpel-free Parkinsons tremor treatment [T-break Tech (Middle East)]
The US Food and Drug Administration has approved a scalpel-free method for treating tremors in medication-resistant Parkinsons disease patients. It was proven to be a safe and effective option for reducing medication-resistant Parkinsons tremor during clinical trials led by University of Virginia School of Medicine neurosurgeon Dr Jeff Elias.
1/17/19 - Generic version of seizure drug Sabril gets FDA approval
A generic version of the seizure drug Sabril (vigabatrin) has been approved by the FDA... The post Generic version of seizure drug Sabril gets FDA approval appeared first on European Pharmaceutical Review.
1/17/19 - Nexus Pharmaceuticals announces FDA approval of Busulfan Injection
Nexus Pharmaceuticals Inc. announced today the U.S. Food and Drug Administration approval of Busulfan Injection, the company's AP-rated therapeutic equivalent for Busulfex 60 mg/10 mL. Nexus Pharmaceuticals Inc., a US-based healthcare company, specializes in innovative processes to make difficult-to-manufacture specialty and generic drugs that..
1/17/19 - Novel Oral Antibiotic Treatment Seysara? (sarecycline) Now Available
Seysara? was approved in October 2018 by the U.S. Food and Drug Administration for the treatment of moderate to severe non-nodular inflammatory acne vulgaris in patients 9 years of age and older, and is now commercially available. "This launch further demonstrates our commitment to our healthcare partners and patients in the U.S.". "Unlike most
1/17/19 - TELA Bio begins commercialization for Large Size OviTex Reinforced BioScaffolds for Hernia Repair and Abdominal Wall Reconstruction after Aroa Biosurgery receives 510k clearance.
By a News Reporter-Staff News Editor at Gastroenterology Week TELA Bio , Inc. and Aroa Biosurgery, the joint developers of OviTex Reinforced BioScaffolds for soft tissue repair, announced 510 clearance from the U.S. Food and Drug Administration to market large sizes of OviTex RBS. The OviTex Permanent product line is now commercially availab
1/16/19 - ABBOTT - FDA APPROVES WORLD'S FIRST DEVICE FOR TREATMENT OF PREMATURE BABIES AND NEWBORNS WITH AN OPENING IN THEIR HEARTS
ABBOTT PARK- Abbott today announced the U.S. Food and Drug Administration approved the Amplatzer Piccolo Occluder, the world's first medical device that can be implanted in the tiniest babies using a minimally invasive procedure to treat patent ductus arteriosus, or PDA. Approximately 60,000 premature babies in the U.S. are born each year with a ve
1/16/19 - AIVITA Biomedical Receives IND Clearance for Phase 1B Melanoma Trial
AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, announced today the U.S. Food and Drug Administration has cleared its Investigational New Drug application for a Phase 1 B clinical trial investigating the Company's ROOT OF CANCER technology in patients with metastatic melanoma. The trial marks the firs
1/16/19 - Amneal Announces Approval of Rivastigmine Transdermal System
BRIDGEWATER- Amneal Pharmaceuticals, Inc., today announced that it has received FDA approval for a generic version of Exelon Patch, 4.6 mg/24 hours, 9.5 mg/24 hours, and 13.3 mg/24 hours. Amneal Pharmaceuticals, Inc., headquartered in Bridgewater, NJ, is an integrated pharmaceutical company focused on developing, manufacturing and distributing gene
1/16/19 - Catheter Stabilization Devices Market Industry Analysis, Size, Share, Growth, Trends And Forecasts (2018-2023)
Catheter Stabilization Devices Market was worth USD 1053.69 Million in 2018 and estimated to be growing at a CAGR of 7.37%, to reach USD 1503.58 Million by 2023.. Medtronic plc's Implantable System for Remodulin to treat patients with pulmonary arterial hypertension has received U.S. Food and Drug Administration approval. Medtronic plc is one of th
1/16/19 - Catheter Stabilization Devices Market Industry Analysis, Size, Share, Growth, Trends And Forecasts (20182023)
Catheter Stabilization Devices Market was worth USD 1053.69 Million in 2018 and estimated to be growing at a CAGR of 7.37%, to reach USD 1503.58 Million by 2023. Recent Developments. Medtronic plc's Implantable System for Remodulin to treat patients with pulmonary arterial hypertension has received U.S. Food and Drug Administration approval.
Articles(s): 1 - 25 of 38     Next >>     Go To Page:


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