Charlotte’s Web Founder Aims For FDA Approval Of Autism Spectrum Disorder Drug
Joel Stanley, the founder and former CEO of Charlotte’s Web, is leading an effort to achieve approval from the FDA for a ...
FDA approves painkiller designed to eliminate the risk of addiction associated with opioids
The Food and Drug Administration approved the pill from Vertex Pharmaceuticals for acute pain that often occurs after surgery ...
JD Supra3d
FDA Publishes Its First Draft Guidance On Use of Artificial Intelligence in the Development of Drugs and Biological Products
On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...
The FDA pulls key DEI initiative for cancer studies from its website
A Food and Drug Administration project to promote diversity in clinical studies of cancer treatments was removed from the ...
JD Supra12d
Drugs and Biologics at FDA: Reflections on 2024 Activity Shed Light on the Road Ahead
With each new year comes a new set of accompanying challenges, from tackling the latest innovations to new incarnations of old issues. 2025 will be ...
The Dangers Hidden In CMS’ Drug Pricing Regulation
The IRA’s price controls discourage post-marketing research. The potential benefits from expanding access to the drug to ...
Yahoo Finance3d
Karolinska Development’s portfolio company Dilafor advances tafoxiparin following successful meetings with FDA and European regulatory authorities
FDA, and European Health Agencies, regarding the continued development of the company’s drug candidate tafoxiparin. The completed meetings mark the end of a comprehensive dialogue with ...
The Conversation29d
Will AI revolutionize drug development? Researchers explain why it depends on how it’s used
Duxin Sun receives funding from the NIH, FDA, and pharmaceutical industries ... AI and machine learning to every stage of the drug development process. This includes identifying targets in the ...