FDAgpt Archives - Page 35 of 41

June 19, 2024 Artificial Intelligence FDAcop

Day One Biopharma Expands into Cancer Biotech with Acquisition of ADCs, Investing $55M for Phase 1-Ready Drug

Day One Biopharmaceuticals, a recently FDA-approved commercial-stage company, is expanding its pipeline by acquiring rights to a novel drug from MabCare Therapeutics. The drug, now renamed DAY301, targets protein-tyrosine kinase 7 (PTK7), which is found in certain cancer cells and pediatric cancers. This drug candidate could potentially compete with a similar drug from Genmab, acquired […]

June 19, 2024 Artificial Intelligence FDAcop

Exclusive Article | Gratitude

The Supreme Court unanimously ruled that The Alliance for Hippocratic Medicine and the doctors it represented did not have adequate proof of standing to sue the FDA, providing the agency relief from potential endless litigation. Standing is the right of a person or organization to sue another entity and is determined by whether the party […]

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 […]

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