Updated drug information handout outdoes FDA's version in clinical trial
A clinical trial comparing a one-page medication handout proposed by the U.S. Food and Drug Administration (FDA) with an ...
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 ...
JD Supra8d
FDA Publishes Its First Draft Guidance On Use of Artificial Intelligence in the Development of Drugs and Biological Products
On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...
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 ...
FiercePharma3d
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 ...
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 ...
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 ...
Boston Herald7d
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 ...
Stars and Stripes7d
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 ...
PharmaTimes10d
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 ...