GlobalData on MSN19h
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 ...
BioSpace10d
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 ...
The Associated Press on MSN13d
FDA approves painkiller designed to eliminate the risk of addiction associated with opioids
The FDA approved a pain drug designed to eliminate the risks associated with opioids -- the first new pharmaceutical approach ...
NKGen Biotech receives U.S. FDA FTD for troculeucel
NKGen Biotech (NKGN) announced that the U.S. Food and Drug Administration, FDA, has granted Fast Track designation, FTD, for the investigation ...
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 ...
manilatimes22h
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, ...
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 ...
Cleveland.com13d
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 ...