New Approvals – Page 27 – media

EU OKs first-line use of AZ’ Faslodex

EU regulators are permitting the use of AstraZeneca’s breast cancer drug Faslodex at an earlier stage of the treatment pathway in patients with certain forms of the disease.
- Source: pharmatimes
- 773
- July 28, 2017
breast cancer EU inhibitor New Approvals
Takeda and BioSurfaces to develop new medical devices for GI indications

Japan's Takeda Pharmaceutical Company has signed an agreement with US-based nanotechnology provider BioSurfaces to develop new therapeutic devices to treat gastrointestinal (GI) diseases.
- Source: Medicaldevice-network
- 427
- July 28, 2017
Company Insight gastrointestinal nanofibrous New Approvals
Sensus gets Chinese regulatory approval for keloid device

US-based Sensus Healthcare has received approval from the China Food and Drug Administration (CFDA) to commercialise its keloid prevention and treatment device, SRT-100. The tool is designed to deliver a precise and calibrated dose of superficial radiation therapy to ensure a skin deep and safe treatment for patients. The low-dose radiation is intended to destroy keloid-causing non-malignant tumour cells, basal cell carcinoma and squamous cell carcinoma without the use of anaesthesia, risk of infection, scarring or the need for reconstructive plastic surgery. Sensus intends to introduce SRT-100 into the country’s market in the fourth quarter of this year through its Chinese partner Chindex Medical, which is a division of Fosun Pharma International. The device will focus on prevention and treatment of keloids associated with Cesarean sections (C-sections). Sensus Healthcare CEO Joe Sardano said: “CFDA clearance of the SRT-100 for the treatment and prevention of keloids is an important milestone for ...
- Source: Medicaldevice-network
- 453
- July 28, 2017
CFDA Company Insight keloid New Approvals
FDA clears BD’s immunological IVD system for commercialization

FDA has granted 510(k) clearance to Becton, Dickinson and Company’s (BD) in-vitro diagnostic (IVD) device, FACSLyric flow cytometer system.
- Source: Medicaldevice-network.com
- 529
- July 27, 2017
Clinical FDA immune New Approvals
Teleflex’s arterial catheterisation device obtains FDA clearance

Teleflex has obtained market clearance from the US Food and Drug Administration (FDA) for its Arrow Seldinger arterial catheterisation device.
- Source: Medicaldevice-network-com
- 456
- July 26, 2017
catheter Company Insight diagnostic FDA New Approvals
Samsung launches new mobile full-body CT scanner

Samsung Electronics’ healthcare unit Samsung NeuroLogica has launched a new mobile, portable full-body computed tomography (CT) scanner, BodyTom Elite.
- Source: Medicaldevice-network-com
- 554
- July 26, 2017
Company Insight CT scanner New Approvals
NICE u-turn backs use of Teva’s asthma biologic

The National Institute for Health and Care Excellence (NICE) is now backing routine NHS commissioning of Teva’s Cinqaero to treat a severe form of asthma after having initially been minded to block the drug’s use.
- Source: pharmatimes
- 467
- July 21, 2017
asthma New Approvals NICE
EU nod for Gedeon’s novel antipsychotic Reagila

European regulators have approved Gedeon Richter’s novel antipsychotic Reagila as a new option for the treatment of patients with schizophrenia.
- Source: pharmatimes
- 479
- July 20, 2017
New Approvals Reagila schizophrenia
Tumor-targeting MRI contrast developed, based on human protein

A team led by Gang Han, PhD, has designed a human protein-based, tumor-targeting Magnetic Resonance Imaging (MRI) contrast that can be easily cleared by the body. The discovery holds promise for clinical application, including early stage tumor detection because of the enhanced MRI contrast, according to Dr. Han, associate professor of biochemistry & molecular pharmacology at University of Massachusetts Medical School.
- Source: drugdu
- 428
- July 7, 2017
breast cancer Clinical New Approvals tumor
Novartis bags first-line approval for Zykadia

The European Commission has expanded the scope of Novartis’ Zykadia to include the first line treatment of patients with non-small cell lung cancer (NSCLC) whose tumours are anaplastic lymphoma kinase (ALK)-positive.
- Source: pharmatimes
- 497
- June 30, 2017
cancer Company Insight New Approvals NSCLC Zykadia

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