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News about "USFDA"
Zydus Secures Final Approval from USFDA for Niacin Extended-Release Tablets
Zydus Lifesciences has received final USFDA approval to manufacture Niacin Extended-Release Tablets in 500 mg, 750 mg, and 1,000 mg dosage, targeting cholesterol management and cardiovascular risk reduction.
USFDA | 30/04/2025 | By Abha
Terumo Neuro Secures FDA Premarket Approval for Carotid Stent System
Terumo Neuro's Carotid Stent System is indicated for the treatment of carotid artery stenosis in patients at increased risk for adverse events following carotid endarterectomy.
USFDA | 16/04/2025 | By Abha | 100
Celltrion's YUFLYMA Achieves FDA Interchangeable Status
YUFLYMA is an FDA-approved, high-concentration (100mg/mL) and citrate-free formulation of Humira® biosimilar, approved for multiple inflammatory indications.
USFDA | 15/04/2025 | By Abha
Innoblative Wins FDA IDE Approval for SIRA Device, Advancing Breast Cancer Surgery Innovation
Innoblative's SIRA device is a single-use, disposable applicator built for intraoperative ablation of the post-lumpectomy cavity during breast conserving surgery.
USFDA | 11/04/2025 | By Abha | 104
B. Braun Medical Receives FDA Approval for Piperacillin, Tazobactam in DUPLEX Drug Delivery System
Piperacillin and Tazobactam in the DUPLEX Drug Delivery System is a ready-to-activate, two-compartment container that keeps pre-measured medication and diluent separate until the provider is ready to administer at the bedside by simply folding, squeezing, and shaking to reconstitute.
USFDA | 10/04/2025 | By Abha
UPLIZNA Becomes First and Only FDA-Approved Therapy for IGG4-Related Disease
The FDA granted Breakthrough Therapy Designation to UPLIZNA for the treatment of IgG4-RD, recognising the high unmet medical need in this serious condition and the medicine's potential to benefit patients.
USFDA | 05/04/2025 | By Abha | 117
Senores Pharmaceuticals Strengthens Global Presence with New USFDA Approvals
The acquisition includes 13 ANDAs that have already received approval from the US Food and Drug Administration (USFDA) and one ANDA that is currently pending approval.
USFDA | 05/03/2025 | By Aishwarya | 123
Orchid Pharma's Alathur API Facility Successfully Completes USFDA Inspection
Orchid Pharma has successfully completed a surprise USFDA inspection at its Alathur API facility, securing its status as India’s only USFDA-approved site for Sterile Cephalosporins. The facility also secures EU GMP certificate renewal for Cephalosporin API manufacturing.
USFDA | 20/02/2025 | By Abha | 129
Rznomics Liver Cancer Drug RZ-001 Secures Fast Track Designation from US FDA
Rznomics' anticancer drug RZ-001 has received Fast Track Designation from the US FDA for the treatment of liver cancer – Hepatocellular Carcinoma (HCC), marking its second designation after Glioblastoma (GBM), to accelerate its clinical development.
USFDA | 19/02/2025 | By Abha | 111
Ventris Medical's Backpack Bone Graft Systems Secure FDA 510(k) Clearance
Backpack® represents a new class of biomaterials designed for the optimisation of cell proliferation and bone formation and is used in orthopedic and spinal fusion procedures.
Usfda | 10/01/2025 | By Abha | 123
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