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The U.S. Food and Drug Administration (FDA) has taken new…
The U.S. Food and Drug Administration (FDA) has taken new steps aimed at fostering the development of non-addictive alternatives to opioids to manage acute pain and decreasing exposure to opioids and preventing new addiction.
The US Food and Drug Administration (FDA) issued an emergency…
The US Food and Drug Administration (FDA) issued an emergency use authorisation for AstraZeneca’s Evusheld for the pre-exposure prophylaxis of COVID-19.
The monoclonal antibody Actemra (tocilizumab) was approved for emergency use…
The monoclonal antibody Actemra (tocilizumab) was approved for emergency use in hospitalised paediatric and adult COVID-19 patients based on results from four clinical trials.
The FDA granted emergency use authorisation to the monoclonal antibody…
The FDA granted emergency use authorisation to the monoclonal antibody sotrovimab as a treatment for mild-to-moderate COVID-19 in certain adult and paediatric patients.
The Emergency Use Authorization (EUA) for bamlanivimab and etesevimab was…
The Emergency Use Authorization (EUA) for bamlanivimab and etesevimab was based on a trial where the antibodies lowered risk of hospitalisation and death in COVID-19 patients.
The FDA has issued an Emergency Use Authorization for baricitinib…
The FDA has issued an Emergency Use Authorization for baricitinib in combination with remdesivir to treat COVID-19 in hospitalised patients.
The FDA is requiring that the prescribing information for nonsteroidal…
The FDA is requiring that the prescribing information for nonsteroidal anti-inflammatory drugs (NSAIDs) include warnings about potential foetal kidney problems if taken by women over 20 weeks pregnant.
Four APIs are being considered by the FDA for its…
Four APIs are being considered by the FDA for its bulk drug substances list for potential use by outsourcing facilities when compounding if there is a clinical need.
Following ongoing analysis and emerging scientific data, the FDA has…
Following ongoing analysis and emerging scientific data, the FDA has taken away its emergency use authorisation for chloroquine and hydroxychloroquine, finding they are unlikely to be effective as COVID-19 treatments.
