FDA Archives - Page 29 of 35

June 18, 2024 Artificial Intelligence FDAcop

Supreme Court Unanimously Resolves FDA’s ‘Standing’ Issue: FDA Today Exclusive

In a recent Supreme Court decision, it was unanimously ruled that The Alliance for Hippocratic Medicine and the doctors it represented did not have adequate proof of standing to sue the FDA. The lower courts had previously allowed the lawsuit to proceed based on a theory that not prescribing mifepristone or treating patients who had […]

June 18, 2024 Artificial Intelligence FDAcop

EMA Expresses Gratitude for New MDR/IVDR Standardization Request, Announces Changes to Deadlines

The European Commission recently adopted a new version of the medical device and diagnostics standardization request, adding more standards and extending deadlines by four years. Harmonized standards are published in the European Union’s Official Journal and provide conformity with essential requirements of regulations. European standards organizations, such as CEN and Cenelec, are responsible for developing […]

June 18, 2024 Artificial Intelligence FDAcop

Study finds insufficient enrollment of women in medical device trials

A recent study published in JAMA Internal Medicine reveals that women continue to be underrepresented in medical device trials, particularly in cardiovascular studies. The research found that from 2010 to 2020, the percentage of women participating in high-risk medical device trials did not increase, with women making up just 33% of participants in trials published […]

July 19, 2023 Artificial Intelligence FDAcop

Novartis to Invest $500M in Acquisition of Preclinical RNA Startup: Here’s the Reason

Swiss pharmaceutical giant Novartis has acquired DTx Pharma for $500 million upfront, with the potential for an additional $500 million in milestones. DTx Pharma has developed an RNA therapy that targets the liver to treat high cholesterol and has a lead drug candidate ready for Phase 1 testing in Charcot-Marie-Tooth (CMT) disease, a rare neuromuscular […]

July 18, 2023 Artificial Intelligence FDAcop

FDA Recap: July 18, 2023

The U.S. Food and Drug Administration (FDA) has provided a summary of recent news from the agency. On Monday, the FDA announced the findings from a pilot program evaluating private third-party food safety audit standards. The program aimed to assess the alignment of these standards with the requirements of the FDA Food Safety Modernization Act […]

July 18, 2023 Artificial Intelligence FDAcop

Eli Lilly Reinforces the Advantages of Early Intervention in Alzheimer’s Treatment

Pharmaceutical giant Eli Lilly has submitted its Alzheimer’s disease drug candidate, donanemab, for FDA review and has released additional clinical data supporting its application. The drug is an anti-amyloid antibody designed to target and break up plaques of amyloid beta, a protein that accumulates in the brain during the progression of Alzheimer’s. The clinical data […]

July 18, 2023 Artificial Intelligence FDAcop

Infants and Toddlers Gain Long-Lasting Protection with FDA Approved RSV Drug

Infants and young children will soon have a new measure of protection against respiratory syncytial virus (RSV), thanks to a drug developed by AstraZeneca and Sanofi. The drug, called nirsevimab and marketed as Beyfortus, was recently approved by the FDA for preventing RSV in newborns, infants, and children up to 24 months of age. This […]

July 18, 2023 Artificial Intelligence FDAcop

AR Surgical Navigation Platform, MediView XR, Secures 510(k) Clearance

MediView XR, a medical technology (medtech) company, has received clearance from the US Food and Drug Administration (FDA) for its augmented reality (AR) surgical navigation system, XR90. This platform allows healthcare providers to visualize and navigate a patient’s internal soft tissues, vascular, organ, and skeletal structures in 3D using CT images. The system also combines […]

July 17, 2023 Artificial Intelligence FDAcop

New Drug Granted FDA Approval for RSV Prevention in Infants and Young Children

The US Food and Drug Administration (FDA) has approved Beyfortus (nirsevimab-alip) as a preventive treatment for Respiratory Syncytial Virus (RSV) lower respiratory tract disease. This approval applies to neonates and infants born or entering their first RSV season, as well as children up to 24 months of age who are vulnerable to severe RSV disease […]

July 16, 2023 Artificial Intelligence FDAcop

Medicare Part D Spending in 2021: 22% Devoted to 10 Prescription Drugs, Report Finds

A new analysis by the Kaiser Family Foundation (KFF) has revealed that despite comprising only 0.3% of total covered drugs, the top 10 best-selling Medicare Part D drugs accounted for 22% of total gross Medicare drug spending in 2021. The findings offer important context for understanding the potential impact of the Medicare Drug Price Negotiation […]

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