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
MDA Applauds FDA Approval of Itvisma, the First Gene Replacement Therapy for a Broad SMA Population

The Muscular Dystrophy Association (MDA)  called the U.S. Food and Drug Administration’s approval of Itvisma (onasemnogene abeparvovec-brve), ...

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
Avenzo Therapeutics Receives FDA Fast Track Designation for AVZO-103 in Urothelial Cancer

-Avenzo Therapeutics, Inc. (“Avenzo”), a clinical-stage biotechnology company developing next-generation oncology therapies, announced the U....

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
AstraZeneca Invests $2 Billion to Expand Maryland Manufacturing, Doubling Biologics Capacity and Advancing U.S. Rare Disease Production

New capacity at AstraZeneca’s Fredrick and Gaithersburg facilities will accelerate production of cancer, rare and chronic disease medicines Four...

November 24, 2025 | Monday | Opinion
MiNK Therapeutics Unveils MiNK-215, an IL-15–Armored FAP-Targeting CAR-iNKT With Potent Anti-Tumor Activity

MiNK-215, an IL-15 armoured FAP-targeting CAR-iNKT, targets and clears tumor-protective FAP+ fibroblasts to allow immune cells to infiltrate and kills ...

November 24, 2025 | Monday | News
Thermo Fisher’s Oncomine Dx Target Test Gains FDA Approval as CDx for Bayer’s Newly Approved HYRNUO™

  Test will serve as a companion diagnostic for Bayer’s HYRNUO™ (sevabertinib) to identify patients with NSCLC eligible for HER2-targeted...

November 20, 2025 | Thursday | News
Psyence BioMed Secures Sustainable, GMP-Compliant Iboga Supply Through PsyLabs to Advance Ibogaine Clinical Development

Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence BioMed” or the “Company”), a biopharmaceutical company advancing nature-derived p...

November 21, 2025 | Friday | News
Alvotech and Advanz Pharma Secure EC Approval for Gobivaz®, the First Simponi® (golimumab) Biosimilar in Europe

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Adva...

November 21, 2025 | Friday | News
Novartis Announces Major North Carolina Expansion as Part of $23B U.S. Infrastructure Investment

Expansion represents significant investment in North Carolina and is expected to create 700 new jobs in the state by end of 2030 Enables manufacturing...

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

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