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FDA grants EUA for Gilead’s remdesivir to treat Covid-19
pharmaceutical-technology
September 01, 2020
The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for Gilead Sciences’ Veklury (remdesivir) to treat all hospitalised patients with Covid-19.
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FDA Clears SPI’s Ebselen for Phase II COVID-19 Trials
contractpharma
September 01, 2020
SPI-1005 is a novel anti-inflammatory drug which was recently shown to inhibit nCoV2 activity and viral replication.
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US FDA willing to give EUA for COVID-19 vaccines before Phase III trials
expresspharma
September 01, 2020
FDA Commissioner also said that it is not a blanket approval and will be subject to benefits outweighing the risks.
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Abbott's fast, $5, 15-minute, easy-to-use COVID-19 antigen test receives FDA Emergency Use Authorization
worldpharmanews
August 31, 2020
Abbott announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its BinaxNOW™ COVID-19 Ag Card rapid test for detection of COVID-19 infection.
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FDA Authorizes First Diagnostic Test Where Results Can Be Read Directly From Testing Card
americanpharmaceuticalreview
August 31, 2020
The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization for the first antigen test where results can be read directly from the testing card, a similar design to some pregnancy tests.
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FDA Works to Mitigate Shortages of Rifampin, Rifapentine Due to Nitrosamine Impurities
americanpharmaceuticalreview
August 31, 2020
The U.S. Food and Drug Administration (FDA) recently became aware of nitrosamine impurities in certain samples of rifampin and rifapentine.
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US FDA approves Winlevi, topical acne treatment from Cassiopea
expresspharma
August 31, 2020
Reportedly, the last FDA approval of an acne drug with a new mechanism of action (MOA) occurred nearly 40 years ago.
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US FDA broadens EUA for Veklury (remdesivir) to treat all hospitalised COVID-19 patients
expresspharma
August 31, 2020
The expansion is supported by the FDA’s analysis of additional data from two randomised, controlled clinical trials that included patients with mild or moderate disease.
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Artificial pancreas for type 1 diabetes control given nod by FDA
europeanpharmaceuticalreview
August 28, 2020
The all-in-one, Control-IQ system controlled the blood glucose levels of children aged six and over more successfully than standard technologies in a clinical trials.
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FDA Removes Amputation Boxed Warning for Canagliflozin
americanpharmaceuticalreview
August 28, 2020
Based on a U.S. Food and Drug Administration (FDA) review of new data from three clinical trials, the FDA has removed the Boxed Warning about amputation risk from the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) prescribing ...