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 ...
The US Food and Drug Administration has approved mirdametinib for the treatment of neurofibromatosis type 1 (NF1) in adults ...
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Biotechs on the Brink: 2 Stocks With Huge PotentialInvestors know the biotech industry is a waiting game—smaller companies in this space often work to secure the funding to ...
U.S.-based PleoPharma announced yesterday that the FDA has granted it a fast-track designation for PP-01, a new ...
Inc. (NASDAQ:OM), a medical technology company focused on innovating dialysis treatment, has resolved all concerns raised in a Warning Letter from the U.S. Food and Drug Administration (FDA) dating ...
Recursion is advancing REC-617, a promising reversible, non-covalent CDK7 inhibitor, showing potential in treating advanced solid tumors with positive interim phase 1 data. Read more here.
In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI) models in ...
On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for ...
Adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas that are not amenable ...
Today, adoption of digital health faces some of the same barriers — scepticism, budget limitations, high expectations, and a ...
Lundbeck has received the US FDA fast track designation for amlenetug, a potential treatment for multiple system atrophy (MSA ...
The Fast Track designation accelerates troculeucel’s path to U.S. FDA submission for the treatment of patients with moderate Alzheimer’s ...
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