Pharmaceutical Technology3h
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 ...
technologynetworks1d
Enhancing Process and Parameter Control for Accelerated Time to Patient
This article explores how digital maturity in process design and parameter management can drive significant time and cost savings, streamline tech transfers and ultimately accelerate patient access to ...
pharmaphorum3h
A well-kept secret: Applying IEPs to accelerate digital health commercial adoption
Today, adoption of digital health faces some of the same barriers — scepticism, budget limitations, high expectations, and a ...
manilatimes5h
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, ...
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 ...
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 ...
Ghana News Agency (GNA) on MSN1d
FDA leads 7 African regulators to foster trust and accelerate access to medicines
The Ghana Food and Drugs Authority (FDA) has spearheaded a joint initiative with National Regulatory Authorities (NRAs) in ...
The Associated Press on MSN12d
FDA approves new painkiller that shows promise and challenges of opioid alternatives
The U.S. Food and Drug Administration said it approved Vertex Pharmaceuticals’ Journavx for short-term pain that often ...
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 ...
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FDA Publishes Its First Draft Guidance On Use of Artificial Intelligence in the Development of Drugs and Biological Products
On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...
Morningstar7d
FDA Accepts Integral Molecular's Membrane Proteome Array™ Qualification Plan, Advancing the Platform for Approval as a Drug Development Tool
is proud to announce that the FDA has accepted their Membrane Proteome Array™ (MPA) Qualification Plan for advancement as a Drug Development Tool (DDT) to assess antibody binding specificity.
JD Supra28d
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 ...