SCOTTSDALE, AZ, October 7, 2025 – CND Life Sciences, Inc. (CND), a medical technology company pioneering the development of cutaneous neurodiagnostic tests and associated biomarker services, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) for the company’s Syn-One Test® for aiding the diagnosis of synucleinopathies in patients aged 40 years and older with neurologic conditions that present with clinical features suggestive of a synucleinopathy.
Category Archives: AZBio News
The Journey of a Plasma Donation
Plasma Donors hold the missing puzzle piece for those who rely on plasma-derived therapies.
October is Plasma Awareness Month, an opportunity for CSL to raise awareness about the importance and need for plasma donations to manufacture life-saving therapies.Continue reading
Amgen Makes Repatha® Available Through AMGENNOW, A Direct-to-Patient Program in the U.S.
Eligible Patients Can Access Repatha at Nearly 60% Discount From the List Price
THOUSAND OAKS, Calif. Oct. 6, 2025 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced the launch of AmgenNow, a new direct-to-patient program starting with Repatha® (evolocumab). This follows landmark results demonstrating Repatha significantly reduced the risk of major adverse cardiovascular events (MACE) in individuals without a prior history of heart attack or stroke in the VESALIUS-CV Phase 3 trial.Continue reading
FDA Announces New ANDA Prioritization Pilot to Support U.S. Generic Drug Manufacturing and Testing
[10/3/2025] Today, the U.S. Food and Drug Administration (FDA) is announcing a new pilot prioritization program for the review of abbreviated new drug applications (ANDAs) (ANDAs) that aims to spur and reward investment in U.S. drug manufacturing and research and development and strengthen the domestic pharmaceutical supply chain by providing faster reviews for generic companies who test and manufacture their products in the U.S.Continue reading
Review and Score ABRC Research Grant Applications
The ABRC relies on subject matter experts (SMEs) from around the globe to evaluate the merits of grant applications received. Research Grant Peer Reviewers review each application in accordance with guidelines provided by ABRC and provide a written review and scores to ABRC.Continue reading
ABRC Request for Grant Applications – Ibogaine Research Clinical Trials
The Arizona Legislature appropriated up to $5,000,000 beginning in fiscal year 2025-2026 to fund phase one (1), two (2), and/or three (3) clinical trials. This funding will run for five (5) years from the date of award and is exempt from lapsing.Continue reading
Falloposcope cancer screening tool testing advances to next steps
Jennifer Barton, PhD, is spearheading an effort to diagnose ovarian cancer earlier and give high-risk patients a new option.Continue reading
AdvaMed Releases Technical Performance and Safety Bulletin on “Remote Device Operations: Common Challenges and Mitigation Strategies”
WASHINGTON, D.C. – AdvaMed, the Medtech Association, recently published a technical performance and safety bulletin titled, “Remote Device Operations: Common Challenges and Mitigation Strategies” to help health care providers, device manufacturers, and IT teams navigate the complex landscape of remotely managing medical devices.Continue reading
U of A celebrates new AI-powered MRI and BIO5 Brain & Body Imaging Center
The new systems represent a leap in non-invasive imaging. The machines, powered by artificial intelligence, open new possibilities for treating neurological diseases such as Alzheimer’s and Parkinson’s, as well as expanding the capabilities for imaging the heart, lungs and liver – even for patients with metallic implants.
Pfizer Reaches Landmark Agreement with U.S. Government to Lower Drug Costs for American Patients
- Voluntary agreement meets the President’s four requests while also protecting the U.S. ecosystem responsible for America’s leadership in delivering medical breakthroughs
- Agreement provides certainty from tariffs and clarity on pricing framework that furthers Pfizer’s ability to expand investment in U.S.-based innovation and return manufacturing to the U.S.
- Pfizer to fully focus on delivering the next generation of cures, especially in cancer, obesity, vaccines, and inflammation and immunology
- Pfizer CEO Albert Bourla joins President Donald J. Trump and members of his Administration in White House event today