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
Taiho Oncology Europe Announces UK Launch of Lytgobi (Futibatinib) for Eligible Patients With Locally Advanced or Metastatic Cholangiocarcinoma

Taiho Oncology Europe GmbH announced the UK launch of Lytgobi® (futibatinib), an irreversibly binding fibroblast growth factor receptor (FGFR) inhibi...

December 04, 2025 | Thursday | News
VANUDIS Implements Cenevo Labguru to Scale Operations and Strengthen Regulatory Readiness

VANUDIS, a biotechnology startup developing the next generation of antibody-based therapeutics, has implemented Cenevo’s Labguru solution to scale ...

December 04, 2025 | Thursday | News
Eisai and Biogen Submit Subcutaneous Lecanemab (LEQEMBI®) Application to Japan’s PMDA

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachuse...

December 01, 2025 | Monday | News
Kedrion Secures EMA Orphan Drug Designation for Investigational Aceruloplasminemia Therapy

  Kedrion announces that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to its investigational treatment for Congenita...

November 28, 2025 | Friday | News
Neuraxpharm Deepens Digital Health Push With AI-Based Seizure Prediction Device EPISERAS®

  A non-invasive, AI-based, wearable earpiece that continuously monitors brain activity to enable the early detection of seizure risk in real time, a...

November 28, 2025 | Friday | 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
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
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

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