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2173 News Found

Insilico Medicine’s AI-designed Parkinson’s drug cleared for human trials by FDA
Clinical Trials | January 29, 2026

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


Truvian Health bags FDA clearance for CBC on TruVerus System
Drug Approval | January 28, 2026

Truvian Health bags FDA clearance for CBC on TruVerus System

TruVerus is the only FDA cleared, multi-modal platform capable of delivering comprehensive routine testing from a single lithium heparin sample


FDA nod to Boehringer Ingelheim's heart disease treatment for dogs 'Vetmedin'
Drug Approval | January 23, 2026

FDA nod to Boehringer Ingelheim's heart disease treatment for dogs 'Vetmedin'

VETMEDIN (pimobendan) chewable tablets and VETMEDIN solution (pimobendan oral solution) can delay the onset of congestive heart failure (CHF) in dogs


iRegene’s Parkinson’s therapy gains FDA designation
News | January 21, 2026

iRegene’s Parkinson’s therapy gains FDA designation

The RMAT designation accelerates the development of regenerative medicine therapies for serious or life-threatening diseases


FDA go ahead for Eli Lilly’s therapy for hard-to-treat ovarian cancer
Drug Approval | January 21, 2026

FDA go ahead for Eli Lilly’s therapy for hard-to-treat ovarian cancer

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


Miach Orthopaedics’ BEAR implant gains FDA label claim for reduced arthritis risk
News | January 17, 2026

Miach Orthopaedics’ BEAR implant gains FDA label claim for reduced arthritis risk

The BEAR Implant is the first sports medicine device to carry a label claim related to lowering PTOA risk


FDA finds no clear link between popular diabetes, weight-loss drugs and suicidal thoughts
News | January 16, 2026

FDA finds no clear link between popular diabetes, weight-loss drugs and suicidal thoughts

The FDA also noted that current prescribing information for GLP-1 RAs already includes warnings about the risk of suicidal thoughts


Zydus receives final approval from USFDA for Eltrombopag Tablets
Drug Approval | January 16, 2026

Zydus receives final approval from USFDA for Eltrombopag Tablets

Eltrombopag tablets will be produced at the group’s formulation manufacturing facility at SEZ, Ahmedabad


EMA and FDA unveil joint AI principles to transform drug revelopment
R&D | January 16, 2026

EMA and FDA unveil joint AI principles to transform drug revelopment

Experts caution that realizing AI’s potential requires careful management and risk mitigation


Camurus’ Oclaiz NDA resubmission accepted by FDA
Drug Approval | January 14, 2026

Camurus’ Oclaiz NDA resubmission accepted by FDA

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 10, 2026