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By Sarah Wicks & Dara Katcher Levy FDAs Office of Prescription Drug Promotion (OPDP) issued its second Untitled Letter of 2025 to Taiho Oncology (Taiho) for a healthcare provider branded website for its drug LYTGOBI (futibatinib). This letter, dated March 21, 2025, cites Taihos false or misleading representations about the benefits of the drug, which is considered misbranding under the Federal Food, Drug, and Cosmetic Act.
Tyler M. McCullough, Vishakha Choudhary, David L. Akey, Meredith A. Skiba, Steffen M. Bernard, Jeffrey D. Kittendorf, Jennifer J. Schmidt, David H. Sherman, and Janet L. Smith ACS Catalysis 2024 14 (16), 12551-12563 DOI: 10.1021/acscatal.4c03637 Emerging antibiotic resistance requires continual improvement in the arsenal of antimicrobial drugs, especially the critical macrolide antibiotics.
On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animal testing in drug development, starting with monoclonal antibodies (mAbs).[ 1] Instead, within 3-5 years, the expectation will be to leverage an integrated safety assessment approach, combining information from a comprehensive battery of New Approach Methodologies (NAM).
Waldmann H, Zhang R, liu J, Gasper R, Janning P. ChemRxiv. 2025 doi:10.26434/chemrxiv-2025-70x40. [link] For targeted covalent protein modification at low reactivity aspartates and glutamates, new methods are in high demand. Inspired by the HaloTag technology we have developed a new technique which employs a reaction between chloroalkane-functionalised ligands and a specific glutamate residue.
Speaker: Simran Kaur, Co-founder & CEO at Tattva.Health
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
SUNDAY, April 13, 2025 -- Curious what recovery really looks like after a hip replacement? Dr. Ayesha Abdeen, chief of hip and knee replacement surgery at Boston Medical Center, shares what to expect at every step along the way from managing pain.
KIF1A.ORG Newsletter April 2025 Welcome Our New Executive Director, Dominique Lessard, Ph.D.! I’m thrilled to share exciting news about the leadership at KIF1A.ORG. Beginning April 14th, Dominique Lessard will officially step into the role of Executive Director , replacing myself, Angie Fuller. Dominique has been a dedicated force within our organization as our previous Chief Science Officer , where she worked tirelessly to bridge scientific research and community impact.
KIF1A.ORG Newsletter April 2025 Welcome Our New Executive Director, Dominique Lessard, Ph.D.! I’m thrilled to share exciting news about the leadership at KIF1A.ORG. Beginning April 14th, Dominique Lessard will officially step into the role of Executive Director , replacing myself, Angie Fuller. Dominique has been a dedicated force within our organization as our previous Chief Science Officer , where she worked tirelessly to bridge scientific research and community impact.
Olezarsen Olezarsen is an ASO directed inhibitor of Apolipoprotein C-III (apoC-III) mRNA, conjugated to a ligand containing three N-acetyl galactosamine (GalNAc) residues to enable delivery of the ASO to hepatocytes. TRYNGOLZA contains olezarsen sodium as the active ingredient. Olezarsen sodium is a white to yellow solid and it is freely soluble in water and in phosphate buffer.
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