Medical device maker DexCom announced Tuesday that the company has received a de novo clearance from the FDA to sell its latest continuous glucose monitoring system — the G6 — that requires no fingerstick calibration.
Recommended for Approval for the Same Indications as Herceptin® (Trastuzumab) Positive Opinion for ABP 980 is Supported by Phase 3 Data in Patients With HER2-Postive Early Breast Cancer
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.
Caris Life Sciences®, a leading innovator in molecular science focused on fulfilling the promise of precision medicine, today announced publication of an article that demonstrated the Company’s proprietary ADAPT Biotargeting System™ (ADAPT) significantly out-performed standard HER2 testing in predicting response to trastuzumab (Herceptin®) for breast cancer patients.
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
Israel approved a plan to invest 1 billion shekels ($275 million) to digitize the personal health records of its nearly 9 million citizens to help develop new drugs.
Novartis today announced that the full results from the Phase III EXPAND study of oral, once-daily siponimod (BAF312) in secondary progressive multiple sclerosis (SPMS) were published in the peer-reviewed journal The Lancet.
Eli Lilly’s one-time blockbuster hopeful baricitinib $LLY is back and on track and ready to run a gamut of outside experts at the FDA.
Patient engagement platform Medical Mindset just landed $1 million in investment capital. The company's platform allows patients to build a HIPAA-compliant health profile, which they can use to check into an appointment by swiping their smartphone.
In collaboration with Google, Facebook, Yahoo and LinkedIn, Ddu recently launched their priority products rally to help users on the platform capture business opportunities, hosting an online medical device product fair to get mass exposure for users' quality products.
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