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
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.
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.
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.
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.
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]).
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.
Abeona Therapeutics Inc. (NASDAQ:ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases, announced today that the FDA has granted Rare Pediatric Disease Designation for the ABO-202 program (AAV-CLN1), an AAV-based gene therapy for the treatment of CLN1 disease (infantile and late infantile onset Batten disease).
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