JD Supra2d
FDA Publishes Its First Draft Guidance On Use of Artificial Intelligence in the Development of Drugs and Biological Products
On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...
EurekAlert!4d
SwRI creating chemical, biological threat mitigation decision support tool for U.S. military
Southwest Research Institute has formed an interdisciplinary team of computer scientists, chemists and biologists to develop software to help the United States Department of Defense (DOD) identify and ...
조선일보6d
K-Bio leaders pursue U.S. factories and conferences during Lunar New Year
K-Bio leaders pursue U.S. factories and conferences during Lunar New Year K-Bio executives opt for international business ...
mRNA-based drugs successfully delivered to intestine—without passing through the liver
Researchers at Tel Aviv University have achieved a breakthrough in drug delivery: they have successfully transported lipid ...
EurekAlert!4d
Rice SynthX and MD Anderson team awarded Kleberg medical grant for brain metastasis research
Rice University chemist and director of the university’s Synthesis X Center Han Xiao and cancer biologist Dihua Yu of The ...
KUNC9h
Trump administration purges websites across federal health agencies
Research and basic information on subjects ranging from tuberculosis surveillance to adolescent health disappeared from ...
Pharmabiz1d
March Biosciences receives US FDA orphan drug designation for MB-105 to treat relapsed/refractory CD5-positive T-cell lymphoma
Biosciences receives US FDA orphan drug designation for MB-105 to treat relapsed/refractory CD5-positive T-cell lymphoma: Houston Thursday, January 30, 2025, 17:00 Hrs [IST] ...
Pharm Exec4d
FDA Approves Supplemental Biologics License Application for Intravenous Maintenance Dosing of Leqembi in Alzheimer Disease
Approval was based on results from multiple studies, which demonstrated a slowing of cognitive decline in patients with ...
Healio2d
‘Don’t give up’: Long-term lebrikizumab for AD may benefit initial nonresponders
Long-term treatment with lebrikizumab may be beneficial for patients with atopic dermatitis that were not initially ...
FDA approves IV maintenance dosing of Leqembi® (lecanemab-irmb) for the treatment of early Alzheimer's Disease in the US
BioArctic AB (publ) (NASDAQ STOCKHOLM: BIOA B) today announced that the U.S. Food and Drug Administration (FDA) has approved BioArctic's partner Eisai's Supplemental Biologics License Application ...
TMCnet3d
March Biosciences Receives FDA Orphan Drug Designation for MB-105, a First-in-Class CD5 CAR-T Cell Therapy, for T-Cell Lymphoma
Beyond an important regulatory milestone, securing orphan drug designation for MB-105 from the FDA underscores the critical need for new therapeutic options for patients with T-cell lymphoma,” said ...