Tag: US Food and Drug Administration
Immuron prepares for diarrhoea-focused clinical trial as US FDA lifts clinical hold
Immuron, an Australia-based biopharmaceutical company, is slated to move forward with the clinical evaluation of a new oral therapeutic targeting Campylobacter and Enterotoxigenic Escherichia coli (ETEC) following approval from the US Food and Drug Administration (FDA).
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.
GMP Pharmaceuticals adds new manufacturing capabilities to Huntingwood HQ
GMP Pharmaceuticals has completed extensive renovations to its global headquarters in Sydney, which now features a series of new facilities such as the dry manufacturing facility and a coating machine designed for processing higher volume batches.
a2 Milk receives FDA discretion to supply infant milk formula to US
The a2 Milk Company announced it has received discretion from the U.S. Food and Drug Administration to supply its a2 Platinum Premium infant milk formula to the U.S. market to help alleviate the ongoing supply crisis.
Pharmaxis’ locally manufactured cystic fibrosis drug lands in the US
Australian pharmaceutical research company Pharmaxis Ltd (ASX:PXS) exported the first shipment of its locally developed and manufactured cystic fibrosis (CF) drug Bronchitol™ (mannitol) to...
Organovo sets out to develop 3D bioprinted liver for direct transplantation
3D biology company Organovo Holdings, Inc. has unveiled plans to develop 3D bioprinted human liver tissue for direct transplantation.
According to the company, the program...
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Building resilience as manufacturing requirements become more complex
The industrial machinery and heavy equipment manufacturing sector is critical not only for its direct outputs, machines, and equipment that pave the way for construction, agriculture and manufacturing but also for its crucial role in economic development and innovation.
