Health
CSOFT’s health blog aims to provide insight into complex diseases, treatment options and regulatory developments, and other prevalent health issues people face today.
ENHERTU® Approved in the U.S. for Patients with HER2 Positive Metastatic Breast Cancer Treated with a Prior Anti-HER2-Based Regimen
Daiichi Sankyo and AstraZeneca’s ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received a prior anti-HER2-based regimen either in the...
BeiGene Announces the Approval in China of BLINCYTO® (Blinatumomab) for Injection for Pediatric Patients with Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia (ALL)
BeiGene a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, announced that the China National Medical Products Administration (NMPA) has granted...
Fast Track Designation in Hand, Graphite Bio Guns for Definitive Sickle Cell Cure
San Francisco-based Graphite Bio announced that it has received Fast Track Designation from the U.S. Food and Drug Administration for its investigational therapy GPH101, which is designed to genetically treat sickle cell disease (SCD). Sickle cell disease has a high...
Horizon Therapeutics plc Receives European Commission (EC) Approval of UPLIZNA® (inebilizumab)
Horizon Therapeutics plc announced the European Commission (EC) approval of UPLIZNA® (inebilizumab) as monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 immunoglobulin G seropositive...
European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) for Patients With Microsatellite Instability-High
Merck , known as MSD outside the United States and Canada, today announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR)...
World’s First FDA Approved Cold Ablative Fiber Laser Makes US Debut
Acclaro Corporation breaks new ground in medical devices for aesthetics with their revolutionary UltraClear™ system. This disruptive technology features a no downtime, painless treatment to address a full spectrum of skin conditions including pigmentation, enlarged...
XVIVO Submits an IDE Application to US FDA for Its Innovative Heart Technology
XVIVO announced the filing of an Investigational Device Exemption (IDE) application to the US Food & Drug Administration (FDA). It will support an initial FDA regulatory approval to conduct the "PRESERVE Clinical Trial: A Prospective, Multi-center, Single-Arm,...
Valneva and Pfizer Report Positive Phase 2 Pediatric Data for Lyme Disease Vaccine Candidate
Valneva SE, a specialty vaccine company, and Pfizer Inc. reported positive Phase 2 pediatric data for their Lyme disease vaccine candidate, VLA15. Based on these new results, Valneva and Pfizer plan to proceed with inclusion of pediatric participants in their planned...
Ardelyx Continues Battle to Secure Approval for Chronic Kidney Disease Drug
Ardelyx announced the U.S. Food and Drug Administration's Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), provided an interim response to the company's second level of appeal for tenapanor. The OND indicated that more input from the...
Biogen Gives Up on EU Approval of Aduhelm Following CHMP Opinion
Biogen has withdrawn its Marketing Authorization Application (MAA) for European approval after regulators hinted the Alzheimer’s drug did not have sufficient enough data to support potential approval. The Boston-based company disclosed the result of a meeting with the...
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