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 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
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 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
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 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 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 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 (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 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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