News about Global Pharma

CIRCA Scientific's PeriCross Access Kit Receives FDA 510(k) Clearance

CIRCA Scientific announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the PeriCross™ Epicardial Access Kit (formerly Rook®), a purpose-built solution designed to enable controlled and efficient access to the pericardial space via a subxiphoid approach.

Global Pharma | 25/04/2025 | By Manvi |  358

Boston Scientific Reports Positive 12-Month FARAPULSE Trial Results

Persistent AF, which accounts for approximately 25 percent 1 of all AF cases, is an abnormal, rapid heartbeat that lasts for at least seven days in a row and can lead to complications such as blood clots, stroke and heart failure.

Global Pharma | 25/04/2025 | By Manvi |  487

Lupin Gets USFDA Approval for Tolvaptan Tablets

Lupin has received US FDA approval for its generic Tolvaptan Tablets, becoming the exclusive first-to-file applicant with 180-day marketing exclusivity in the US. The tablet is used for the treatment of autosomal dominant polycystic kidney disease (ADPKD). It will be manufactured in the company’s Nagpur facility.

Global Pharma | 25/04/2025 | By Manvi |  565

Landmark BioVentures and G.CLIPS Biotech Form Strategic Alliance to Bridge Gaps in Drug Target Engagement

Landmark BioVentures and G.CLIPS Biotech have announced a strategic alliance to strengthen early-stage drug development by addressing critical gaps in target engagement and physiopathology, enhancing efficiency and reducing risk across the development pipeline.

Global Pharma | 24/04/2025 | By Manvi |  327

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 |  246

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 |  218

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 |  300

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 |  480

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 |  805

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 |  845