Bayer Initiates Phase IIa ASSESS Trial of Investigational Antibody BAY 3401016 for Alport Syndrome

BAY 3401016 is an investigational monoclonal antibody with potential to block a protein called Semaphorin 3A (Sema3A), which is thought to be involve...

December 05, 2025 | Friday | News
Insulet Receives FDA Clearance for Major Omnipod 5 Algorithm Upgrade Featuring New 100 mg/dL Target Glucose Setting

New 100 mg/dL Target Glucose setting offers more customization and tighter glucose management. Enhanced algorithm helps users remain in Automated Mo...

December 05, 2025 | Friday | News
Roche’s 15-Minute PCR Test for Whooping Cough Receives FDA Clearance and CLIA Waiver

The point-of-care test delivers PCR-accurate results in just 15 minutes, enabling healthcare providers to act quickly and prevent severe complications ...

December 02, 2025 | Tuesday | News
Cullinan’s FLT3-Targeted T Cell Engager CLN-049 Receives FDA Fast Track for R/R AML

Promising efficacy and favorable safety data from the Phase 1 study in heavily pre-treated patients show potential of CLN-049 to address a broad populati...

December 02, 2025 | Tuesday | News
Regeneron and Tessera Partner on One-Time Gene Writing Therapy for Alpha-1 Antitrypsin Deficiency

TSRA-196 is a potential one-time treatment to precisely correct the genetic mutation underlying AATD, with Investigational New Drug filing expected by ...

December 02, 2025 | Tuesday | News
BeOne Medicines’ Sonrotoclax Granted FDA Priority Review for Relapsed or Refractory Mantle Cell Lymphoma

BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, announced that the U.S. Food and Drug Administration (FDA) has a...

November 27, 2025 | Thursday | News
AstraZeneca’s IMFINZI Plus FLOT Receives US Approval as First Neoadjuvant Immunotherapy for Early Gastric and GEJ Cancers

AstraZeneca’s IMFINZI® (durvalumab) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxe...

November 27, 2025 | Thursday | News
GE HealthCare Receives FDA Authorization for Pristina Recon DL, a Breakthrough in AI-Enhanced 3D Mammography

GE HealthCare (Nasdaq: GEHC) announced that it has received FDA Premarket Authorization for Pristina Recon DL, an advanced 3D mammography image reconstru...

November 27, 2025 | Thursday | News
Sarepta Receives FDA Approval to Initiate Cohort 8 Evaluating Sirolimus With ELEVIDYS in Non-Ambulant Duchenne

Approximately 25 non-ambulatory participants will receive sirolimus as part of the regimen in Cohort 8 of the ENDEAVOR study, which is expected to be...

November 26, 2025 | Wednesday | News
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
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
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
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
Oncolytics Biotech Gains FDA Agreement on Pivotal Study Design for Pelareorep in First-Line Metastatic Pancreatic Cancer

Company to launch only current registration trial with an immunotherapy in first-line pancreatic cancer in first half of 2026 Trial design allows flex...

November 20, 2025 | Thursday | News

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