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COVID-19 exposed supply chain problems that should have pharmaceutical manufacturers rethinking their standard procedures — from sourcing manufacturing materials to getting completed product safely into customer hands, — says one regulatory compliance expert. Read More
Paxlovid is currently FDA-authorized for treatment of mild-to-moderate COVID-19 in adults and pediatric patients 12 years of age and older weighing at least 40 kg. Read More
The panel concluded that the absence of in vitro neutralization activity strongly suggests absence of clinical effectiveness of these monoclonal antibodies. Read More