Pharmaceutical Technology54m
Lundbeck gains FDA fast track designation for MSA therapy amlenetug
Lundbeck has received the US FDA fast track designation for amlenetug, a potential treatment for multiple system atrophy (MSA ...
JD Supra13d
FDA Publishes Its First Draft Guidance On Use of Artificial Intelligence in the Development of Drugs and Biological Products
On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...
BioSpace9d
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 ...
Acsh.org1d
Rare Diseases Are Neglected. The FDA Needs A Dedicated 'Center of Excellence for Rare Diseases'.
The FDA has made some modest efforts, but it needs an internal organization that understands and would be an aggressive ...
manilatimes2h
NKGen Biotech Receives U.S. FDA Fast Track Designation for Troculeucel for the Treatment of Moderate Alzheimer's Disease
NKGen is a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic NK cell therapeutics. NKGen is headquartered in Santa Ana, ...
FDA Accepts Integral Molecular's Membrane Proteome Array™ Qualification Plan, Advancing the Platform for Approval as a Drug Development Tool
Integral Molecular, a leader in antibody discovery technologies, is proud to announce that the FDA has accepted their ...
Cleveland.com12d
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 ...
CBS News12d
FDA OK's painkiller designed to end opioids' addiction and overdose risk
Washington — Federal officials on Thursday approved a new type of pain drug designed to eliminate ... medication's modest effectiveness and lengthy development process underscore the challenges ...