Tag Archive for: FDA Approval

Novo Holdings leads $105 million financing of Magenta Medical to support FDA approval for world’s smallest heart pump

Funds will be used to advance Magenta’s US clinical programs to support the FDA’s approval of the Elevate™ System, the world’s smallest heart pump Eric Snyder, Partner, Venture Investments, Novo Holdings will join Magenta Medical Board of Directors Boston, US, 23 July 2024 – Novo Holdings, a leading life science investor, today announces that it has […]

Calliditas Therapeutics announces full FDA approval of TARPEYO®, the only FDA-approved treatment for IgA nephropathy to significantly reduce the loss of kidney function

Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”), today announced that the U.S. Food and Drug Administration (FDA) has approved TARPEYO (budesonide) delayed release capsules to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. TARPEYO was first approved in December 2021 under accelerated […]

Zephyrus Innovations appoints David Whitaker as Chief Technology Officer

Vancouver, Canada – 30 May 2023: Zephyrus Innovations (Zephyrus), a privately-owned medical device company designing and manufacturing safety syringes and Closed System Transfer Devices (CSTDs), today announces the appointment of David Whitaker as Chief Technology Officer. David brings with him more than 20 years’ experience in the development and manufacture of medical devices. Until recently, […]

Zephyrus Innovations announces US FDA approval for its Aeroject™ 3ml safety syringe

Aeroject™ 3ml safety syringe is a single-use, affordable, first generation syringe Aeroject™ has a permanently attached needle system, which upon retraction, fully encases the needle, preventing needle reuse and accidental needlestick The ultra-low wasted space syringes allow for the maximum number of doses to be administered per vial, lowering costs 16 February 2023 – Vancouver, Canada: […]