FDA
Differentia Bio's AI models matched later clinical outcomes
Differentia Bio says its disease-modeling platform identified therapeutic mechanisms between 2023 and 2024 that were later supported by independent clinical results. One…
DxCheck Launches DxPro, a Free AI Workspace for Verified U.S. Clinicians
DxCheck has launched DxPro, an AI-powered workspace for practicing U.S. healthcare professionals that combines cited clinical answers, daily specialty updates and…
Vanda's NEREUS Cuts Semaglutide-Induced Vomiting in Phase III Trial
Vanda Pharmaceuticals says its oral drug NEREUS (tradipitant) significantly reduced vomiting caused by semaglutide in the Phase III Study 3601. The company plans to…
Products and toolsFDA Approves Subcutaneous Induction for AbbVie's Skyrizi in Crohn's Disease
The U.S. Food and Drug Administration has approved a subcutaneous induction regimen for AbbVie's Skyrizi (risankizumab-rzaa) in adults with moderately to severely active…
FDA clears BoneEnhance, first machine learning layer for RIVANNA's Accuro XV
The U.S. Food and Drug Administration has granted 510(k) clearance for BoneEnhance, a machine learning software module for RIVANNA's Accuro XV diagnostic ultrasound…
ResearchFull-Life's c-MET tracer FL-261 shows high lesion contrast in first NSCLC patients
Full-Life Technologies has presented first-in-human imaging data for [111In]In-FL-261, a c-MET-targeted radiotracer, in 10 patients with non-small cell lung cancer.…
EY: MedTech M&A hits decade high as AI and blockbuster deals drive growth
The global MedTech industry is at a turning point, according to the 20th edition of EY's Pulse of the MedTech Industry report. Record financing and the strongest M&A in…
FDA Clears Protego's PROT-001 for Phase 2/3 Trial in AL Amyloidosis
The U.S. Food and Drug Administration has cleared the Investigational New Drug application for PROT-001, Protego Biopharma said. The clearance lets the company start…
FDA Grants Orphan Drug Designation to Vivacta Bio's In Vivo CAR-T Therapy GT801
The U.S. Food and Drug Administration has granted Orphan Drug Designation to GT801, an investigational in vivo CAR-T therapy from Vivacta Bio, for autoimmune hemolytic…
Cancer Diagnostics Market Seen Reaching $41.5 Billion by 2031, Wissen Research Says
The global cancer diagnostics market is valued at USD 29.3 billion in 2026 and is projected to reach USD 41.5 billion by 2031, a CAGR of 7.2%, according to a new study…
Law firm seeks lead plaintiff in securities class action against Beta Bionics
The Law Offices of Frank R. Cruz says investors who lost money on Beta Bionics, Inc. (BBNX) have a chance to lead a securities fraud class action. The complaint alleges…
AnX Robotica Cites FDA Data Showing 88.6% Cut in Capsule Review Time
AnX Robotica says FDA documents show its NaviCam ProScan AI reading technology reduced mean small-bowel capsule endoscopy review time by 88.6%, compared with 24.7%…
Iambic files IND for IAM217, a brain-penetrant KIF18A inhibitor designed with AI
Iambic Therapeutics has submitted an Investigational New Drug application to the U.S. FDA for IAM217, a brain-penetrant inhibitor of KIF18A, to start a Phase 1/2 trial.…