New Approvals – Page 13 – media

ViiV Healthcare gains CHMP Positive Opinion for Juluca (dolutegravir/rilpivirine) in Europe

ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a Positive Opinion recommending marketing authorisation for Juluca (dolutegravir/rilpivirine) for the treatment of HIV infection in adults
- Source: Viivhealthcare
- 455
- March 28, 2018
HIV Juluca New Approvals
TiGenix and Takeda announce Alofisel® (darvadstrocel) receives approval to treat complex perianal fistulas in Crohn’s disease in Europe

First allogeneic stem cell therapy to receive central marketing authorization approval in Europe. Alofisel offers a new treatment option for patients who do not respond to current available therapies and may be subject to numerous invasive surgeries1
- Source: tigenix
- 598
- March 27, 2018
Alofisel EC New Approvals perianal fistulas Takeda
Lokelma approved in the EU for the treatment of adults with hyperkalaemia

AstraZeneca announced that the European Commission has granted marketing authorisation for Lokelma (formerly ZS-9, sodium zirconium cyclosilicate) for the treatment of adults with hyperkalaemia. Hyperkalaemia is a serious condition characterised by elevated potassium levels in the blood associated with cardiovascular, renal and metabolic diseases.
- Source: Worldpharmanews
- 576
- March 27, 2018
hyperkalaemia Lokelma New Approvals
UCSD researchers develop wearable, 24-hour GI tract monitor

A wearable device, developed by researchers at the GI Innovation Group out of the University of California San Diego, can track electrical activity in the stomach over a 24-hour period. The device works similarly to how an ECG would work for the heart, but instead it monitors the electrical activities of gastrointestinal tract.
- Source: MobiHealthNews
- 549
- March 27, 2018
digital health New Approvals wearables
Smiths Medical touts FDA nod, US launch of DeltaVan catheter

Smiths Medical today touted the FDA clearance and US launch of Delta Med’s DeltaVan closed system catheter.
- Source: MassDevice
- 569
- March 26, 2018
catheter FDA medical device products New Approvals
FDA expands approval of Adcetris for first-line treatment of Stage III or IV classical Hodgkin lymphoma in combination with chemotherapy

The U.S. Food and Drug Administration today approved Adcetris (brentuximab vedotin) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy.
- Source: finance.yahoo
- 586
- March 22, 2018
ADCETRIS cancer FDA Hodgkin lymphoma New Approvals
Oxford Performance Materials targets Asia after 3D printed medical devices approved in Japan

Oxford Performance Materials, a company whose materials have been used in everything from medical implants to Boeing airplanes, has been given the green light to distribute its 3D printed medical devices in Japan, paving the way for major expansion within Asia.
- Source: 3Ders
- 536
- March 22, 2018
3D printing Japan medical device products New Approvals
Bayer receives approval in China for Stivarga® (regorafenib) for the second-line systemic Treatment of liver cancer (for specialized target groups only)

Bayer reported that the Chinese Food and Drug Administration (CFDA) approved Stivarga (regorafenib) tablets for the second-line treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar (sorafenib) (Press release, Bayer, DEC 13, 2017, View Source [SID1234522618]).
- Source: 1stoncology
- 532
- March 20, 2018
HCC New Approvals Nexavar® Stivarga®
FDA Approves Hizentra® (Immune Globulin Subcutaneous 20% Liquid) for the Treatment of Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

First and only subcutaneous immunoglobulin (SCIg) approved for the treatment of CIDP based on the largest controlled clinical study in CIDP
- Source: finance.yahoo
- 688
- March 20, 2018
CIDP FDA Hizentra® New Approvals
Implantable sensor relays real-time personal health data to a cell phone

Personalized medicine is one step closer for consumers, thanks to tiny, implantable sensors that could give an early warning of a person's developing health problems, indicate the most effective type of exercise for an individual athlete, or even help triage wounded soldiers. That's the vision for a family of devices that scientists are now developing. They have begun marketing their first device in Europe and hope to win approval for this technology in the U.S.
- Source: TechExplore
- 551
- March 20, 2018
digital health healthcare technologies and innovations New Approvals

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