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Regulatory

The US FDA Reclassifies Certain High-Risk IVDs

The US FDA Reclassifies Certain High-Risk IVDs

  • February 5, 2024
The US FDA Approved Recor Medical and Otsuka Medical Devices’ Paradise Ultrasound Renal Denervation System for Hypertension

The US FDA Approved Recor Medical and Otsuka Medical Devices’ Paradise Ultrasound Renal Denervation System for Hypertension

  • November 9, 2023
Mustang Bio Reports the US FDA’s Acceptance of IND Application for MB-109 to Treat Recurrent Glioblastoma and High-Grade Astrocytoma

Mustang Bio Reports the US FDA’s Acceptance of IND Application for MB-109 to Treat Recurrent Glioblastoma and High-Grade Astrocyto...

  • October 27, 2023
Cidara Therapeutics & Mundipharma received a Positive opinion from the EU’s CHMP for Rezzayo (Rezafungin) to Treat Invasive Candidiasis

Cidara Therapeutics & Mundipharma received a Positive opinion from the EU’s CHMP for Rezzayo (Rezafungin) to Treat Invasive Candid...

  • October 13, 2023
Hansa Biopharma Receives Positive Reimbursement Decision for Idefirix (imlifidase) in the Czech Republic

Hansa Biopharma Receives Positive Reimbursement Decision for Idefirix (imlifidase) in the Czech Republic

  • January 2, 2023
DePuy (J&J)’s Teligen System Receives the US FDA Approval for User-Centric Procedural Control During Spine Surgery

DePuy (J&J)’s Teligen System Receives the US FDA Approval for User-Centric Procedural Control During Spine Surgery

  • October 21, 2022
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