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 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FDA Publishes Its First Draft Guidance On Use of Artificial Intelligence in the Development of Drugs and Biological Products
On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...
FDA approved the first new kind of pain medication in 27 years. Here’s how it works
The FDA just approved a new type of pain medication, and it's a non-opioid called suzetrigine that stops body pain at its ...
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 ...
JD Supra18d
FDA Issues Draft Guidances on AI in Medical Devices, Drug Development: What Manufacturers and Sponsors Need to Know
The Food and Drug Administration (FDA) has recently released two draft ... its architecture and development process, describing in detail datasets and subsets used in training and tuning including ...
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 ...
Targeted Oncology5d
FDA Grants FTD to 64Cu-SAR-bisPSMA for PET Imaging in Prostate Cancer
The FDA granted fast track designation to 64Cu-SAR-bisPSMA for PET imaging of PSMA-positive prostate cancer lesions in ...
Morningstar3d
Advicenne Reaches a Significant Milestone With the US FDA in the Development of ADV7103 in Cystinuria
provides an update on recent exchanges with the U.S. FDA (Food and Drug Administration) about the development of ADV7103 in cystinuria, and announces that it has reached an important milestone.
PharmaTimes4d
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 ...
SiliconRepublic12d
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 ...