RT-PCR test detects and differentiates SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus
This product will be manufactured at Lupin’s Pithampur facility In India
The filing includes data from PROVENT Phase III trial showing 77% reduction in risk of developing symptomatic Covid-19 with a long-acting antibody combination (non-vaccine)
The company plans to submit the IND application by the end of 2021
According to industry sales data, the 10mg strength of Afinitor generated annual sales of US $ 392 million during the twelve months ending July 2021
If cleared, Merck's drug would be the first pill shown to treat Covid-19, a potentially major advance in efforts to fight the pandemic
Droxidopa capsules, 100 mg, 200 mg, and 300 mg is a generic equivalent of Northera capsules, 100 mg, 200 mg, and 300 mg, of Lundbeck NA
The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial in people with early AD and confirmed amyloid pathology
It is the first orally administered therapy for the treatment of two types of ANCA-associated vasculitis approved in Japan
The FDA also approved Repatha as an adjunct to other LDL-C lowering therapies for the treatment of homozygous familial hypercholesterolemia (HoFH) for younger pediatric patients
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