Tag: FDA approval
FDA OKs manufacturing of Anteris’ aortic valve replacement at Minnesota facility
Anteris Technologies announced that the US Food and Drug Administration (FDA) has approved the manufacturing of DurAVR THV, a 3D single-piece aortic heart valve replacement, at the company's recently expanded production facility in Maple Grove, Minnesota.
IDT Australia has filed an ANDA for Temozolomide approval
IDT Australia Limited (ASX:IDT) has filed an Abbreviated New Drug Application (ANDA) with the U.S Food and Drug Administration (FDA) for approval to market...
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Don’t get left behind: Manufacturing’s urgent need for digital transformation
As digital transformation reshapes industries worldwide, manufacturers in Australia and beyond are finding themselves at the forefront of an evolution. This shift presents opportunities for companies looking to improve efficiency, drive innovation, and boost growth.
