Valneva Seeks to Expand IXCHIQ® Chikungunya Vaccine Use to Adolescents in Europe and Canada

Valneva SE , a specialty vaccine company, announced the submission of label extension applications to the European Medicines Agency (EMA) and Hea...

September 18, 2024 | Wednesday | News
BeiGene Secures Israeli Ministry of Health Approval for TEVIMBRA® in Treating Esophageal Squamous Cell Carcinoma

BeiGene, a global oncology company, announced that the Israeli Ministry of Health (IL MOH) has approved TEVIMBRA® (tislelizumab) as monotherapy for t...

September 18, 2024 | Wednesday | News
T2 Biosystems Gains FDA Clearance for Pediatric Use of T2Candida® Panel

T2 Biosystems, Inc. (NASDAQ:TTOO) (the “Company”), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance gene...

September 17, 2024 | Tuesday | News
FDA Approves Roche’s OCREVUS ZUNOVO™ for Subcutaneous MS Treatment, Expanding Access for Patients

OCREVUS ZUNOVO™ has the potential to expand treatment options to centres without IV infrastructure or with IV constraints, like at a doctor's off...

September 16, 2024 | Monday | News
MaxCyte and Kamau Therapeutics Partner to Advance Next-Gen Gene Therapies for Sickle Cell Disease

MaxCyte, Inc.,  a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and comme...

September 16, 2024 | Monday | News
Vasa Therapeutics' Novel Heart Failure Treatment VS-041 Reaches Key Clinical Advancement with First Dosing in Human Trials

VS-041, a novel and potentially life-saving  treatment for heart failure, developed by Vasa Therapeutics, a San Diego-based biotechnology  comp...

September 11, 2024 | Wednesday | News
Dupixent Phase 3 Study Shows Significant Reductions in Itch and Hives for Patients with Chronic Spontaneous Urticaria (CSU)

Dupixent phase 3 study confirms significant improvements in itch and hives for patients with CSU Confirming the results of CUPID-A, this second pivot...

September 11, 2024 | Wednesday | News
PolTREG’s PTG-007 Treg Therapy Shows Long-Term Remission in Type-1 Diabetes, Up to 12 Years in Some Patients

PTG-007 cell therapy resulted in clinical remission in some patients for up to 12 years A proportion of patients remained insulin-independent for up t...

September 09, 2024 | Monday | News
Roche Expands Digital Pathology Platform with Over 20 AI Algorithms to Enhance Cancer Research and Precision Medicine

The Roche Digital Pathology Open Environment brings together a wide array of innovative AI-based pathology tools to help clinicians...

September 09, 2024 | Monday | News
European Medicines Agency Grants Orphan Drug Designation to SeaBeLife's SBL01 for Acute Liver Failure

Orphan designation shows recognition of therapeutic potential of drug candidate SBL01 targeting two regulated cell death pathways European Medicines A...

September 04, 2024 | Wednesday | News
Valneva and Pfizer Report Positive Phase 2 Results for Lyme Disease Vaccine Candidate, VLA15, Following Second Booster Dose

Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) and Pfizer Inc. (NYSE: PFE) today announced positive results from the VLA15-221 Phase 2 study of t...

September 03, 2024 | Tuesday | News
Novavax Prepares to Launch Protein-Based COVID-19 Vaccine in Thousands of U.S. Locations with Pre-Filled Syringes

Novavax expects pre-filled syringes will be broadly available in thousands of locations across the U.S. Novavax's vaccine is the only protein-based op...

September 02, 2024 | Monday | News
Emergent BioSolutions Secures FDA Approval to Expand ACAM2000® Vaccine Indication for Mpox Prevention Amid Global Health Emergency

Emergent BioSolutions announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (s...

August 30, 2024 | Friday | News
HUTCHMED Voluntarily Withdraws Supplemental NDA for Fruquintinib in China, Cites Need for Further Evaluation in Gastric Cancer Treatment

HUTCHMED announces that it has voluntarily withdrawn its supplemental New Drug Application (“NDA”) in China for fruquintinib in combination w...

August 30, 2024 | Friday | News

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