Novartis Announces FDA Approval of Kisqali® for Expanded Use in Early Breast Cancer, Doubling Eligible Patient Population

– Novartis announced that the U.S. Food and Drug Administration (FDA) has approved Kisqali® (ribociclib) in combination with an aromata...

September 18, 2024 | Wednesday | News
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
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 Grants Seven Years of Market Exclusivity to YORVIPATH for Treating Hypoparathyroidism in Adults

U.S. FDA Orphan Drug exclusivity provides seven years of market exclusivity for YORVIPATH in the United States for the treatment of hypoparathyroidism in...

September 12, 2024 | Thursday | 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
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
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
Pensar Medical and Centurion Therapeutics Partner to Expand Access to Advanced Wound Care with Innovative Microdoc® sNPWT System

Pensar Medical, a leading innovator in negative pressure wound therapy (NPWT), today announced a strategic partnership with Centurion Therapeutics for ...

August 30, 2024 | Friday | News
Johnson & Johnson Submits First Global Application for Nipocalimab, Pioneering Treatment for Generalized Myasthenia Gravis

Johnson & Johnson  announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for nipocali...

August 30, 2024 | Friday | News
Celltrion USA Expands Patient Access to ZYMFENTRA® Through Agreement with Cigna and Express Scripts

Celltrion USA announced that it has signed an agreement with Cigna Healthcare, the health benefits provider of the Cigna Group and Express Scripts, the p...

August 29, 2024 | Thursday | News
AC Immune's Partner LMI Receives FDA Fast Track Designation for PI-2620 in Alzheimer's and Other Neurodegenerative Diseases

  PI-2620 is in Phase 3 development in Alzheimer’s disease by AC Immune’s partner, LMI This Fast Track designation applies across Al...

August 28, 2024 | Wednesday | News

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