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News & Blog


Industry News: FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans

The FDA issued a final rule to improve access to hearing aids which may in turn lower costs for millions of Americans. This action establishes a new category of over-the-counter (OTC) hearing aids, enabling consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription or a fitting adjustment by an audiologist.
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Industry News: Brain MRI surveillance needed for TKl-treated ALK or ROS7-positive NSCLC

Retrospective data showed how common central nervous system metastases are among patients with non-small cell lung cancer and ALK or ROS1 alterations who have been treated with tyrosine kinase inhibitors.
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Industry News: Completion of Enrollment in Pivotal Phase 3 Trial of TAVT-45 for the Treatment of Metastatic Prostate Cancer

Novel Oral Suspension Formulation of Abiraterone Acetate Designed to Address Needs of Metastatic Prostate Cancer Patients Who Have Difficulty Swallowing (Dysphagia), an Issue for 20 to 30 Percent of Prostate Cancer Patients
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Industry News: Two new studies substantiate prune’s role in bone health and digestive health

More than a simple snack, prunes have achieved superfood status due to their known benefits on bone, digestive, and cardiovascular health. Now, two new studies add further evidence to confirm the positive role that prunes have on overall health.
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Industry News: FDA Clears DyAnsys Neurostimulation Device First Relief to treat Diabetic Neuropathic Pain

First Relief, a PENS (percutaneous electrical neurostimulation) device, has been cleared by the FDA for multiple treatments up to 56 days for symptomatic relief of chronic, intractable pain from diabetic peripheral neuropathy. It is applied behind the ear and delivers continuous pulses of a low-level electrical current over several days.
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Industry News: Insightec receives FDA IDE approval for prostate cancer comparative study using high intensity focused ultrasound

Insightec announced that it has received FDA approval for an investigational device exemption (IDE) for a clinical comparative study of the Exablate Prostate system used to treat diseased prostate tissue. This study will evaluate the safety and efficacy of focal treatment using high intensity focused ultrasound when compared to active surveillance in men living with prostate cancer.
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