Aidoc Sets New Benchmark in Clinical AI With Foundation Model FDA Submission and 100M Real-World Cases

Aidoc, the global leader in clinical AI with the most FDA-cleared CAD solutions,  announced a major milestone: the completion of its pivotal study a...

November 26, 2025 | Wednesday | News
EMD Serono Advances First Potential Oral gMG Therapy with FDA Fast Track Designation

  Cladribine capsules have the potential to be the first oral treatment for people living with rare, chronic autoimmune neuromuscular disorder, g...

November 25, 2025 | Tuesday | News
GE HealthCare Advances CT Innovation with 510(k) Submission for Photonova™ Spectra Photon-Counting System

GE HealthCare announced the submission of a 510(k) to the U.S. FDA seeking clearance for Photonova™ Spectra, its new photon-counting computed ...

November 25, 2025 | Tuesday | Regulatory
MindImmune Closes $10.2M Series A Extension to Advance First-in-Class Alzheimer’s Therapeutic

MindImmune Therapeutics, a private company developing new treatments targeting the inflammatory drivers of neurodegenerative disease, announced two major...

November 25, 2025 | Tuesday | News
ADVANCE®AI Partners with Microsoft to Transform Real-World HCP Insights Through AI

ADVANCE®AI, a leading innovator in pharmaceutical-specific AI solutions, is excited to announce our acceptance into the Microsoft for Startups Pegasu...

November 25, 2025 | Tuesday | News
NeuroThera Labs and Clearmind File Israeli Patent for Novel MEAI–PEA Combination Therapy Targeting Depression

SciSparc Ltd. announced that NeuroThera Labs Inc. , a clinical-stage pharmaceutical company focused on developing novel treatments for central nervous sy...

November 21, 2025 | Friday | News
Dexcom Receives FDA Clearance for Smart Basal, a First-of-Its-Kind AI-Powered Basal Insulin Dosing Solution

-DexCom, Inc. (NASDAQ: DXCM), the global leader in glucose biosensing, announced today the FDA has cleared Dexcom Smart Basal, the first and only CGM-int...

November 20, 2025 | Thursday | News
Harrow Enters Procedural Sedation Market With Acquisition of Melt Pharmaceuticals

Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America,  announced that it has completed the acquisit...

November 19, 2025 | Wednesday | News
PrognomiQ Launches ProVue Lung, a Blood-Based Test Designed for Earlier Lung Cancer Detection

Initial commercial availability begins through an Early Experience Program with Penn Highlands Healthcare and Allegheny Health Network –  Pr...

November 19, 2025 | Wednesday | News
Thermo Fisher Scientific Enrolls First Patient in New PPD™ CorEvitas™ Myasthenia Gravis Registry

  Thermo Fisher Scientific Inc., the world leader in serving science, announced the enrollment of the first patient in the new PPD™ CorEvitas&t...

November 18, 2025 | Tuesday | News
Scotland Strengthens Position as Global Brain Health Innovator With New Alzheimer’s Research Centre in Aberdeen

Aberdeen clinical research centre widens access to clinical trials across Scotland, advancing early Alzheimer’s research ONE BioHub provides Scott...

November 18, 2025 | Tuesday | News
Sarepta Announces Prescribing Information Update for ELEVIDYS Gene Therapy

Sarepta Therapeutics, Inc. the leader in precision genetic medicine for rare diseases,  announced an update to the prescribing information for ELEVI...

November 17, 2025 | Monday | News
Amneal Earns FDA Approval for First Generic Iohexol, Targeting $652M U.S. Market

Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (Nasdaq: AMRX) today announced the U.S. Food and Drug Administration (FD...

November 17, 2025 | Monday | News
Legend Biotech Expands U.S. R&D Footprint With New Philadelphia Innovation Center

Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a U.S.-based global leader in cell therapy,  announced the official opening and ribbon c...

November 17, 2025 | Monday | News

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