News about Global Pharma

CGBIO's NOVOSIS PUTTY Wins FDA IDE Approval for US Spinal Trial

CGBIO's NOVOSIS PUTTY Wins FDA IDE Approval for US Spinal Trial

This milestone marks NOVOSIS PUTTY as the first Korean-developed bio-combined medical device to reach this stage in the US, signifying a significant step toward Premarket Approval (PMA) and subsequent commercialization.

Global Pharma | 24/04/2025 | By Manvi 283

SimonMed Partners with Lunit to Advance AI-Powered Breast Cancer Detection

SimonMed Partners with Lunit to Advance AI-Powered Breast Cancer Detection

SimonMed has selected Lunit INSIGHT DBT™, in combination with Volpara Analytics™, as the most advanced AI solution for breast cancer screening after an extensive evaluation of technologies on the market.

Global Pharma | 24/04/2025 | By Manvi 240

Veravas Launches VeraBIND Tau, First Blood Test to Aid Alzheimer's Detection

Veravas Launches VeraBIND Tau, First Blood Test to Aid Alzheimer's Detection

The first-in-class assay is available now as a laboratory-developed test (LDT) through Veravas. It was validated and is performed in a CLIA / CAP certified lab.

Global Pharma | 23/04/2025 | By Manvi 315

Epiminder's Minder EEG Implant Wins FDA De Novo, Breakthrough Status for Epilepsy

Epiminder's Minder EEG Implant Wins FDA De Novo, Breakthrough Status for Epilepsy

Epiminder announced that it has been granted FDA authorisation via the De Novo classification for Minder, its proprietary implantable continuous electroencephalogram monitoring system (iCEMTM) for patients with epilepsy.

Global Pharma | 23/04/2025 | By Manvi 493

Eugia Pharma Secures USFDA Approval for Dasatinib Tablets

Eugia Pharma Secures USFDA Approval for Dasatinib Tablets

Aurobindo Pharma's subsidiary, Eugia Pharma Specialities, has received final USFDA approval to manufacture and market Dasatinib Tablets in varying dosages for the treatment of certain types of leukemia. The product is expected to be launched in Q1 FY26.

Global Pharma | 23/04/2025 | By Manvi 836

Caplin Steriles Secures USFDA Approval for Phytonadione Injectable Emulsion

Caplin Steriles Secures USFDA Approval for Phytonadione Injectable Emulsion

Caplin Steriles Ltd., a subsidiary of Caplin Point Laboratories, has received final USFDA approval for its generic Phytonadione Injectable Emulsion USP (10 mg/mL), a therapeutic equivalent to Hospira's Vitamin K1 Injection.

Global Pharma | 23/04/2025 | By Manvi 875

Suanfarma Appoints Mane Godina as its New CEO

Suanfarma Appoints Mane Godina as its New CEO

Suanfarma has appointed Pere Mañé Godina as its new CEO, ushering in a new phase focused on industrial consolidation, sustainable innovation, and global expansion.

Global Pharma | 22/04/2025 | By Manvi 264

Jazz Pharmaceuticals Acquires Chimerix for USD 935 Million

Jazz Pharmaceuticals Acquires Chimerix for USD 935 Million

Jazz Pharmaceuticals plc has completed its USD 935 million acquisition of Chimerix, Inc., making it a wholly owned subsidiary and strengthening its oncology portfolio with the addition of the novel drug candidate Dordaviprone.

Global Pharma | 22/04/2025 | By Manvi 249

BD Launches AI-Powered Hemodynamic Monitoring Platform to Enhance Patient Safety During Procedures

BD Launches AI-Powered Hemodynamic Monitoring Platform to Enhance Patient Safety During Procedures

BD (Becton, Dickinson and Company) has launched a new advanced hemodynamic monitoring platform with predictive, artificial intelligence (AI) based algorithms that can help clinicians proactively address blood pressure instability and optimize blood flow to help avoid potential life-threatening situations during procedures.

Global Pharma | 22/04/2025 | By Manvi 250

ARUP Laboratories Introduces pTau 217 Blood Test to Support Alzheimer's Disease Diagnosis in Older Adults

ARUP Laboratories Introduces pTau 217 Blood Test to Support Alzheimer's Disease Diagnosis in Older Adults

ARUP Laboratories now provides a blood test for phosphorylated tau 217 (pTau 217) to assist in identifying whether cognitive decline symptoms in patients ages 60 years and older are related to Alzheimer's disease (AD) pathology.

Global Pharma | 22/04/2025 | By Manvi 485

 
 

 

 

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