News about Global Pharma

Stryker Receives US FDA 510(k) Clearance for Incompass Total Ankle System

Stryker announced it has received US Food and Drug Administration (FDA) 510(k) clearance for the Incompass® Total Ankle System, an implant intended for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.

Global Pharma | 27/06/2025 | By Manvi |  143

Avivomed Appoints Dan Brounstein as CEO and Board Member

Steve Brounstein has succeeded CEO Steve Masson, who retired from his role in May and will continue to work with the company in an advisory role.

Global Pharma | 27/06/2025 | By Abha |  431

Acclaro Medical's UltraClear Laser Receives Health Canada Approval, Partners with Xcite for Nationwide Rollout

Acclaro Medical has also partnered with Xcite Technology to spearhead commercialisation efforts across Canada.

Global Pharma | 27/06/2025 | By Abha |  546

US FDA Approves Expanded Indications for GE HealthCare's Vizamyl PET Imaging Agent

GE HealthCare’s Vizamyl PET imaging agent has received FDA approval for an expanded label, now allowing quantification of amyloid plaques and use in monitoring Alzheimer’s therapy – advancing precision and confidence in diagnosis and care decisions.

Global Pharma | 26/06/2025 | By Manvi |  136

Sysmex America Receives FDA Clearance for CN-6000 Automated Blood Coagulation Analyzer

Sysmex America, Inc. has received FDA clearance for the CN-6000™ Automated Blood Coagulation Analyzer. Sysmex will continue efforts to obtain market authorization for the Automated Blood Coagulation Analyzer CN-3000 and additional reagent applications.

Global Pharma | 26/06/2025 | By Manvi |  143

Embolization Secures 510(k) Clearance for Non-Metal Coil Device

Using proprietary shape-memory biocompatible polymers, Embolization's coil devices achieve better vascular occlusion while minimizing artifacts in CT and MRI imaging that occur with traditional metal devices.

Global Pharma | 26/06/2025 | By Manvi |  188

Capricor Therapeutics Updates on Deramiocel BLA for Duchenne Muscular Dystrophy

Capricor Therapeutics has announced progress on its Biologics License Application for Deramiocel, its lead cell therapy for DMD-associated cardiomyopathy, with the FDA maintaining Priority Review and no Advisory Committee meeting planned ahead of the August 31, 2025 PDUFA date.

Global Pharma | 26/06/2025 | By Manvi |  207

Lupin Secures US FDA Approval for Prucalopride Tablets

Lupin has received US FDA approval for its generic Prucalopride Tablets, 1 mg and 2 mg, for the treatment of chronic idiopathic constipation (CIC) in adults. This product will be manufactured at Lupin's Goa facility in India.

Global Pharma | 25/06/2025 | By Manvi |  207

Nitinotes Receives FDA Approval to Initiate Pivotal Trial for EndoZip Suturing System

Nitinotes, developer of the EndoZip™ System announced it has received approval from the U.S. Food and Drug Administration (FDA) to initiate a pivotal clinical trial under an Investigational Device Exemption (IDE).

Global Pharma | 25/06/2025 | By Manvi |  185

Illumina to Acquire SomaLogic for USD 350 Million to Accelerate its Proteomics Business

Illumina has announced a definitive agreement to acquire proteomics firm SomaLogic and other assets from Standard BioTools for up to USD 425 million, strengthening its multiomics strategy and expanding its footprint in the fast-growing proteomics market.

Global Pharma | 24/06/2025 | By Manvi |  157