Bayer today announced that its collaboration partner Loxo Oncology, Inc., (NASDAQ: LOXO), a biopharmaceutical company based in Stamford, Connecticut (US), has completed the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
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
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]).
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