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Acclaro Medical has also partnered with Xcite Technology to spearhead commercialisation efforts across Canada.
Global Pharma | 27/06/2025 | By Abha | 457
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 | 122
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 | 117
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 | 144
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 | 176
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 | 178
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 | 155
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 | 134
Cerapedics Receives FDA Approval for PearlMatrix Bone Graft
Cerapedics Inc. announced the U.S. Food and Drug Administration (FDA) premarket approval (PMA) of PearlMatrix™ P-15 Peptide Enhanced Bone Graft as a Class III drug-device combination product for use in single-level transforminal lumbar interbody fusion (TLIF) surgery in adult patients with degenerative disc disease (DDD).
Global Pharma | 24/06/2025 | By Manvi | 842
Glenmark Launches TEVIMBRA in India for Lung and Esophageal Cancer Treatment
Glenmark Pharmaceuticals has launched TEVIMBRA (tislelizumab) in India, marking its entry into immuno-oncology with a globally approved PD-1 inhibitor for advanced lung and esophageal cancers.
Global Pharma | 24/06/2025 | By Manvi | 190
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