News about Global Pharma

Cycle Pharmaceuticals' HARLIKU Gets FDA Approval

Cycle Pharmaceuticals announced that the FDA has approved HARLIKU (nitisinone) Tablets for the reduction of urine homogentisic acid (HGA) in adult patients with AKU.

Global Pharma | 30/06/2025 | By Manvi |  142

FDA Clears Archeus' IND for Prostate Cancer Therapy ART-101

Archeus Technologies announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ART-101, a novel receptor-based targeting small molecule that Archeus has developed for the imaging and treatment of prostate cancer.

Global Pharma | 30/06/2025 | By Manvi |  274

Alembic Pharmaceuticals Secures USFDA Final Approval for Doxorubicin Hydrochloride Liposome Injection

Alembic Pharmaceuticals has received final USFDA approval for its generic Doxorubicin Hydrochloride Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) Single-Dose Vials, for the treatment of Ovarian Cancer, AIDS-Related Kaposi’s Sarcoma, and Multiple Myeloma.

Global Pharma | 30/06/2025 | By Manvi |  229

Ancora Heart Hits Enrollment Goal in CORCINCH-HF Trial for HFrEF Therapy

Ancora Heart, Inc. announced that it has reached the first enrollment milestone in the CORCINCH-HF pivotal trial evaluating the AccuCinch® Transcatheter Left Ventricular Restoration System in patients with heart failure with reduced ejection fraction (HFrEF).

Global Pharma | 27/06/2025 | By Manvi |  156

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 |  124

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 |  382

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 |  496

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 |  127

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 |  130

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 |  159