FDA Approves First New Non-Opiod Painkiller in Decades
Journavx is designed to eliminate the risks of addiction and overdose associated with medications like Vicodin and OxyContin.
JD Supra1d
FDA Publishes Its First Draft Guidance On Use of Artificial Intelligence in the Development of Drugs and Biological Products
On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...
What Is Journavx? First Pain Medication Approved by FDA in Over Two Decades
This milestone marks a breakthrough after unsuccessful attempts to develop painkillers without the addictive potential of ...
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 ...
technologynetworks11d
Exploring the Frontiers of Pharmaceutical Innovation
Each regulatory body, such as the FDA in the US or the EMA in Europe ... phase-appropriate quality system is one of the greatest hurdles in the drug development process. AI and machine learning are ...
Texas Public Radio3d
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 ...
PharmaTimes3d
Cartesian Therapeutics announces FDA agreement for new trial
Cartesian Therapeutics has secured an agreement from the US Food and Drug Administration (FDA) under the Special Protocol ...
SiliconRepublic11d
CergenX making Waves with new FDA designation
Irish neurotech company CergenX has received the Breakthrough Device Designation from the US FDA while being accepted into ...