Search Results for “FDA” – Page 59 – media

FDA backs GSK’s Tafenoquine for Malaria Cure

Sanction of a single 300mg dose of GlaxoSmithKline’s tafenoquine in patients 16 years and above for the "radical cure" of malaria was advocated by an FDA advisory committee on finding significant evidence for its efficacy and safety.
- Source: MedPageToday
- 4,417
- July 16, 2018
FDA GSK malaria New Approvals
FDA Clearance for Echonous Vein Ultrasound

EchoNous announced that it has been granted FDA 510(k) clearance for its EchoNous Vein ultrasound device which could improve peripheral IV catheter placements. This system could provide real-time clear mages of superficial and deeper veins.
- Source: The Verge
- 5,594
- July 16, 2018
FDA medical device New Approvals ultrasound
FDA Clears First Autonomous AI Diagnostic System Rolled out by University of Iowa Healthcare

The U.S. Food and Drug Administration approved the first autonomous artificial intelligence diagnostic system, IDx-DR and the University of Iowa Healthcare has become the first healthcare organization to implement it.
- Source: HealthcareIT News
- 938
- July 15, 2018
AI digital health New Approvals
Bristol-Myers Squibb’s Combo Drug gets FDA Approval

Bristol-Myers Squibb’s recent immunotherapy combo won FDA approval for patients with a rare colon cancer. The combinational medicine was formulated between an older medicine named Yervoy and a new cancer-fighter Opdivo. This combo drug focuses on repairing the mismatch gene.
- Source: FiercePharma
- 4,403
- July 13, 2018
Bristol-Myers Squibb cancer colorectal cancer New Approvals
FDA Clearance for Algorithm that Quantifies Coronary Artery Calcification

Kibbutz Shefayim from an Israel-based startup company named Zebra Medical Vision announced that it has successfully received FDA clearance for an algorithm, which could aid physicians to quantify a patient’s coronary artery calcification.
- Source: MobiHealthNews
- 718
- July 13, 2018
coronary arteries FDA New Approvals
FDA Rebukes Chinese API maker Sichuan Friendly Pharmaceutical in Warning Letter

The FDA sent a warning letter to Sichuan Friendly Pharmaceutical after listing it in the import alert list due to its abysmal performance during a fall inspection. The FDA was not pleased with the manufacturing methods it saw at the Chinese API maker’s facility.
- Source: FiercePharma
- 737
- July 9, 2018
FDA pharmaceutical company Policies
FDA Approves Pulmonx’s Zephyr Device to Treat Emphysema

The premarket approval of Pulmonx’s Zephyr Endobronchial Valve to treat severe emphysema has green-lighted by the FDA. Zephyr is a pencil eraser-sized device delivered directly to the lung in a minimally invasive procedure. After the successful delivery, the device stops air from entering diseased parts of the lung during breathing. This mechanism prevents the air from getting trapped by damaged alveoli and stops the breathing difficulties.
- Source: FierceBiotech
- 881
- July 4, 2018
emphysema FDA medtech New Approvals
Array BioPharma gets FDA Approval for Melanoma Combo

The U.S, Based Array BioPharma received FDA approval for its much-awaited BRAFTOVI capsules with the combination of MEKTOVI tablets for the treatment of patients with metastatic melanoma with a BRAFV600E or BRAFV600K mutation.
- Source: FiercePharma
- 588
- June 28, 2018
cancer Melanoma New Approvals
FDA Approval for Eversense – Continuous Glucose Monitoring System

The FDA has finally approved to market the implantable continuous glucose monitoring system named Eversense, from Senseonics, in the United States.
- Source: MobiHealthNews
- 942
- June 27, 2018
diabetes digital health mHealth New Approvals
FDA Approval for Cannabis Based Epidiolex Medicine Against Seizures

Epidiolex, also known as purified cannabidiol was approved to treat Lennox-Gastaut syndrome and Dravet syndrome specifically in patients aged 2 and older. Both these conditions start during childhood. Recurrent seizures pose a huge risk of death.
- Source: FiercePharma
- 563
- June 27, 2018
FDA Medical marijuana New Approvals

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