JD Supra9d
FDA Publishes Its First Draft Guidance On Use of Artificial Intelligence in the Development of Drugs and Biological Products
On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...
BioSpace4d
What Trump’s Second Term Could Mean for PDUFA’s Future
Trump's pick for HHS secretary who endured confirmation hearings last week—has repeatedly criticized industry ties to the FDA ...
Healio5h
Researchers stress need for clear, consistent standards in FDA review of psychiatric drugs
The FDA approved 16 psychiatric drugs over the last decade, most of which shared similar mechanisms of action with previously ...
Drugmaker to study pig kidney transplants in humans with groundbreaking trial
FDA clears United Therapeutics for human trials of pig-to-human kidney transplants. Trial involves gene-edited pig kidneys ...
FDA OK's painkiller designed to end opioids' addiction and overdose risk
Federal officials approved a new type of pain drug designed to eliminate the risks of addiction and overdose associated with opioid​ medications like Vicodin and OxyContin.
FiercePharma4d
Pfizer's Braftovi combo on track for full approval in win for FDA's Project FrontRunner
Less than two months after an accelerated approval from the FDA, a drug combination featuring Pfizer’s Braftovi has turned in ...
Boston Herald8d
FDA approves new painkiller that shows promise and challenges of opioid alternatives
Thousands of Costco workers prepare to strike with midnight contract deadline looming The U.S. Food and Drug Administration ... effectiveness and lengthy development process underscore the ...
Cleveland.com7d
FDA approves new painkiller designed to avoid opioid addiction risk
The U.S. Food and Drug Administration said it approved ... But the medication’s modest effectiveness and lengthy development process underscore the challenges of finding new ways to manage ...
Stars and Stripes8d
FDA approves painkiller designed to eliminate the risk of addiction associated with opioids
The U.S. Food and Drug Administration said it approved ... But the medication’s modest effectiveness and lengthy development process underscore the challenges of finding new ways to manage ...
Morningstar9d
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.