Valneva Faces US FDA Suspension of IXCHIQ® Vaccine Licence After New Safety Reports

Valneva SE , a specialty vaccine company, announced that the United States Food and Drug Administration (FDA) has suspended the license for IXCHIQ&r...

August 25, 2025 | Monday | News
Terumo Acquires OrganOx in $1.5 Billion Deal to Transform Global Organ Transplantation

- Expanding opportunities for organ transplantation worldwide and contributing to the advancement of transplant medicine - Terumo Corporation announced ...

August 25, 2025 | Monday | News
Cube Biotech’s NativeMP™ Technology Powers First-Ever DEL Screening of Membrane Proteins with X-Chem

Cube Biotech, a pioneer in membrane protein stabilization and purification, and X-Chem, the global leader in DNA-Encoded Library (DEL) technology and dat...

August 22, 2025 | Friday | News
Alvotech and Advanz Pharma Secure European Commission Approval for Mynzepli®, a Biosimilar to Eylea®

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

August 22, 2025 | Friday | News
Novocure Submits PMA to FDA for Tumor Treating Fields Therapy in Pancreatic Cancer

Novocure announced it submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for Tumor Treating Fields (TTFields...

August 21, 2025 | Thursday | News
Enanta Pharmaceuticals Files Patent Infringement Suit Against Pfizer in EU Unified Patent Court Over Paxlovid™

-Enanta Pharmaceuticals, Inc. (NASDAQ: ENTA), a clinical-stage biotechnology company dedicated to creating novel, small molecule drugs for viral infectio...

August 21, 2025 | Thursday | News
Idorsia’s TRYVIO™ Included in New ACC/AHA Hypertension Guidelines as a Novel Treatment Option

Idorsia Ltd (SIX: IDIA) announces that its novel dual endothelin receptor antagonist (ERA), TRYVIO™ (aprocitentan), has been included in the new co...

August 20, 2025 | Wednesday | News
European Commission Approves OGSIVEO® as First-Ever Therapy for Desmoid Tumours

SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany, announced that the European Commission (EC) granted marketing aut...

August 19, 2025 | Tuesday | Regulatory
Sanofi Advances Rare Disease Pipeline as Rilzabrutinib Gains EMA Orphan Status in IgG4-RD

Data from the positive Phase 2 study evaluating rilzabrutinib for the treatment of IgG4-related disease presented at EULAR 2025 Additional orphan desi...

August 18, 2025 | Monday | News
Ascentage Pharma Receives FDA and EMA Clearance for Global Phase III Trial of Lisaftoclax in Higher-Risk MDS

Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and c...

August 18, 2025 | Monday | News
MAIA Biotechnology Secures European Patent for Next-Generation Telomere-Targeting Cancer Therapies

MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on dev...

August 14, 2025 | Thursday | News
China’s Kexing Biopharm Forms Strategic Alliance with IQVIA to Accelerate Global Drug Development and Commercialisation

 Kexing Biopharm (688136.SH) has officially entered into a comprehensive strategic partnership with IQVIA(NYSE:IQV), a global leader in clinica...

August 12, 2025 | Tuesday | News
Sartorius and Nanotein Forge Strategic Alliance to Advance Immune Cell Manufacturing

Nanotein’s NanoSpark® reagents enhance cell activation and expansion in cell therapy manufacturing Exclusive global distribution agreement...

August 12, 2025 | Tuesday | News
Nyxoah Secures FDA Approval for Genio System to Treat Moderate to Severe Obstructive Sleep Apnea

Nyxoah SA , a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, ann...

August 11, 2025 | Monday | News

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