Insilico Medicine’s AI-designed Parkinson’s drug cleared for human trials by FDA
The upcoming Phase I trial will test the safety, tolerability, and pharmacokinetics of ISM8969 in healthy volunteers and determine the optimal dosing for future studies
The upcoming Phase I trial will test the safety, tolerability, and pharmacokinetics of ISM8969 in healthy volunteers and determine the optimal dosing for future studies
TruVerus is the only FDA cleared, multi-modal platform capable of delivering comprehensive routine testing from a single lithium heparin sample
VETMEDIN (pimobendan) chewable tablets and VETMEDIN solution (pimobendan oral solution) can delay the onset of congestive heart failure (CHF) in dogs
The RMAT designation accelerates the development of regenerative medicine therapies for serious or life-threatening diseases
Sofetabart mipitecan is a novel folate receptor alpha (FR?) antibody-drug conjugate (ADC) leveraging proprietary linker technology and an exatecan payload to target tumor cells
The BEAR Implant is the first sports medicine device to carry a label claim related to lowering PTOA risk
The FDA also noted that current prescribing information for GLP-1 RAs already includes warnings about the risk of suicidal thoughts
Eltrombopag tablets will be produced at the group’s formulation manufacturing facility at SEZ, Ahmedabad
Experts caution that realizing AI’s potential requires careful management and risk mitigation
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 10, 2026
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