The company continues to cooperate with the US FDA and is committed to undertake all necessary steps required to address their observations at the earliest
Ascletis is China's first biotech company which has obtained IND approvals of an oral RdRp inhibitor from both China NMPA and the U.S. FDA
OrderPoint was designed as an advanced DTR solution from its first release in 2016.
The OAI classification implies that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved
QIAstat-Dx Viral Vesicular Panel tests for six pathogens that produce similar symptoms
Investment in response to increased demand for North American-based chemistry services
AI-driven company anumana partnered with Novartis to drive the development of its electrocardiogram (ECG) AI algorithms to detect subclinical heart disease.
Company will invest approximately ¥16 billion to increase production capacity by approximately 70% to ensure a stable supply
The audit is part of the agency's inspection for three product applications filed and slated to be manufactured at this site.
Driven by a strong commitment to better serve its global customers in medical and consumer products, this investment represents the largest capacity expansion in Cariflex’s existing accomplishments
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