policymed.com13d
FDA Releases Draft Guidance on the Accelerated Approval Process
The United States Food and Drug Administration (FDA) recently released a draft guidance, Expedited Program for Serious ...
Cure Today1d
FDA Grants Fast Track Designation to AUTX-703 In R/R AML
The Food and Drug Administration granted fast track designation to AUTX-703 for relapsed or refractory acute myelogenous ...
GlobalData on MSN13d
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 Supra12d
A Model’s Credibility Is in the Details: FDA Draft Guidance on the Use of AI Models in Drug and Biological Product Development
In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI) ...
CRISPR: From Discovery To Clinic—And Charting A Path Forward
No doubt 2025 will usher in many more advances in CRISPR therapies, thanks to the FDA’s new Platform Technology Designation ...
Pharmabiz11d
US FDA grants fast track designation to NKGen Biotech’s natural killer cell therapy, troculeucel to treat moderate Alzheimer’s disease
US FDA grants fast track designation to NKGen Biotech’s natural killer cell therapy, troculeucel to treat moderate Alzheimer’s disease: Santa Ana, California Saturday, Februar ...
Business Wire8d
U.S. FDA Accepts Gilead’s New Drug Applications for Twice-Yearly Lenacapavir for HIV Prevention Under Priority Review
--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration ... by the FDA in October 2024. The Breakthrough Therapy Designation process ...