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US FDA warns against co-administration of remdesivir and chloroquine or HCQ
expresspharma
June 17, 2020
The drug regulator informs that this may reduce the antiviral activity of remdesivir and lessen the effectiveness of COVID-19 treatment.
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US FDA revokes EUA for chloroquine and hydroxychloroquine
expresspharma
June 17, 2020
The known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorised use, said the drug regulator.
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Zydus Cadila gets final US FDA approval for Deferasirox Tablets
expresspharma
June 17, 2020
It is used to treat iron overload caused by blood transfusions in adults and children who are at least two years old.
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FDA, NTIA Announce Pilot Program to Stop Illegal Availability of Unapproved Opioids Online
americanpharmaceuticalreview
June 16, 2020
The U.S. Food and Drug Administration (FDA) and the National Telecommunications and Information Administration (NTIA) are launching a 120-day pilot to help reduce the availability of unapproved opioids illegally offered for sale online.
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Adamas Announces FDA Filing Acceptance of sNDA to Modify Indication Statement for GOCOVRI
americanpharmaceuticalreview
June 16, 2020
Adamas Pharmaceuticals announced its supplemental New Drug Application (sNDA) for GOCOVRI as a treatment for OFF episodes in Parkinson’s disease (PD) patients receiving levodopa-based therapy ...
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FDA Publicly Shares Antibody Test Performance Data from Kits as Part of Validation Study
americanpharmaceuticalreview
June 16, 2020
The U.S. Food and Drug Administration (FDA) publicly posted test performance data from four more antibody, or serology, test kits on open.fda.gov from its independent performance validation study effort with the National Institutes of Health’s (NIH) ...
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FDA approves ViiV Healthcare’s Tivicay to treat HIV in children
pharmaceutical-technology
June 16, 2020
ViiV Healthcare has received approval from the US Food and Drug Administration (FDA) for Tivicay PD (dolutegravir) tablets, in combination with other antiretroviral agents, to treat children with human immunodeficiency virus type 1 (HIV-1) infection.
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FDA revokes authorisation for anti-malarials to treat Covid-19
pharmaceutical-technology
June 16, 2020
The US Food and Drug Administration (FDA) has revoked the emergency use authorisation (EUA) for anti-malarials, chloroquine phosphate and hydroxychloroquine sulfate, to treat some hospitalised Covid-19 patients.
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FDA Grants Orphan Drug Designation for Brain Cancer Drug Berubicin
contractpharma
June 16, 2020
Accelerates its development to treat malignant gliomas and provides CNS with the potential for market exclusivity.
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FDA Authorizes Next-Gen Sequence Test for Diagnosing COVID-19
contractpharma
June 16, 2020
The FDA authorized the Illumina COVIDSeq Test for the qualitative detection of SARS-CoV-2 RNA from respiratory specimens collected from individuals suspected of COVID-19.