News about Global Pharma

FDA Classifies Q'Apel Medical's Recall of 072 Aspiration System as Class I

FDA Classifies Q'Apel Medical's Recall of 072 Aspiration System as Class I

US Food and Drug Administration, classified Q'Apel Medical, Inc.'s voluntary recall of 1,617 units of its 072 Aspiration System (also known under the product name 'Hippo', which includes 'Cheetah'; collectively, the 'product') as Class I.

Global Pharma | 21/04/2025 | By Manvi |  292

Zydus MedTech Partners with Braile Biomedica to Commercialise TAVI Technology

Zydus MedTech Partners with Braile Biomedica to Commercialise TAVI Technology

Zydus MedTech has partnered with Brazil-based Braile Biomedica to exclusively commercialise its advanced Transcatheter Aortic Valve Implantation (TAVI) technology across Europe, India, and select global markets, marking its strategic entry into the interventional cardiology space.

Global Pharma | 21/04/2025 | By Manvi |  594

Alembic Pharmaceuticals Secures USFDA Final Approval for Carbamazepine Tablets

Alembic Pharmaceuticals Secures USFDA Final Approval for Carbamazepine Tablets

Alembic Pharmaceuticals has received final USFDA approval for its Abbreviated New Drug Application (ANDA) for Carbamazepine Tablets USP, 200 mg, a generic version of Tegretol used as an anticonvulsant and for treating trigeminal neuralgia.

Global Pharma | 21/04/2025 | By Manvi |  286

Lupin Secures EIR from US FDA for its Injectable Facility in Nagpur

Lupin Secures EIR from US FDA for its Injectable Facility in Nagpur

Lupin has received the Establishment Inspection Report (EIR) from the US FDA for drug-device combination products at its injectable manufacturing facility in Nagpur, India.

Global Pharma | 21/04/2025 | By Manvi |  1207

RND Automation Acquires QuickPouch's Intellectual Property and Asset

RND Automation Acquires QuickPouch's Intellectual Property and Asset

With this acquisition, RND plans to improve the QuickPouch product line and integrate it into their renowned packaging solutions, including the MiniPack, MicroPack, and Kanga Poucher.

Global Pharma | 19/04/2025 | By Manvi |  387

FDA Approves Medtronic's Simplera Sync Sensor for Use with MiniMed 780G System

FDA Approves Medtronic's Simplera Sync Sensor for Use with MiniMed 780G System

With this approval, the MiniMed™ 780G system now offers more flexibility for users of the company's most advanced insulin delivery system featuring Meal Detection™ technology with both the Guardian™ 4 sensor and Simplera Sync™ sensor.

Global Pharma | 19/04/2025 | By Manvi |  768

EBR Systems Secures FDA Approval for WiSE System to Treat Advanced Heart Failure

EBR Systems Secures FDA Approval for WiSE System to Treat Advanced Heart Failure

Unlike conventional CRT, the WiSE System is the first and only to deliver leadless left ventricular endocardial pacing (LVEP), that closely aligns with the heart's natural conduction pathway.

Global Pharma | 19/04/2025 | By Abha |  696

WuXi Biologics Completes First Commercial PPQ Campaign at MFG20 Hangzhou Facility

WuXi Biologics Completes First Commercial PPQ Campaign at MFG20 Hangzhou Facility

WuXi Biologics completes the first commercial project Process Performance Qualification (PPQ) campaign for its three sets of 5,000L single-use bioreactors (SUBs).

Global Pharma | 19/04/2025 | By Abha |  356

DOSIsoft Unveils PLANET Onco Dose v3.2 with EU MDR and FDA 510(k) Clearance

DOSIsoft Unveils PLANET Onco Dose v3.2 with EU MDR and FDA 510(k) Clearance

DOSIsoft announces the latest release of PLANET® Onco Dose version 3.2: a customized, voxel-based, multi-radionuclide dosimetry platform for SIRT and MRT, now market approved in the EU under the MDR CE mark and in the US with FDA 510(k) clearance.

Global Pharma | 17/04/2025 | By Manvi |  422

Zydus Lifesciences' VC Arm Invests in Canada's Feldan Therapeutics to Advance Intracellular Drug Delivery

Zydus Lifesciences' VC Arm Invests in Canada's Feldan Therapeutics to Advance Intracellular Drug Delivery

Feldan's proprietary Shuttle peptide technology enables the efficient and targeted delivery of biomolecules into cells, unlocking new therapeutic possibilities.

Global Pharma | 17/04/2025 | By Abha |  680

 
 

 

 

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