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FDA Commissioner Stephen Hahn issued an apology Tuesday for the way he portrayed the effectiveness of convalescent plasma as a COVID-19 treatment during the announcement of the FDA’s Emergency Use Authorization (EUA) — but he stressed the independence of the agency in its regulatory decisions amidst concerns of political pressure. Read More
The World Health Organization said that 172 countries — out of the world’s total of 195 nations — are taking part in its Covax initiative, a global COVID-19 vaccine access program. Read More
Moderna announced that it has concluded exploratory talks with the European Commission for a deal to supply up to 160 million doses of its COVID-19 vaccine. Read More
The World Health Organization (WHO) has expressed doubts about the FDA’s decision to grant an Emergency Use Authorization (EUA) for convalescent plasma as a COVID-19 treatment, claiming that the supporting evidence is weak. Read More
AstraZeneca has denied claims that it is in talks with the U.S. government about receiving a potential Emergency Use Authorization (EUA) for its COVID-19 vaccine candidate. Read More
When determining whether to issue an EUA for a multi-analyte respiratory panel that includes SARS-CoV-2, the agency said it considers the clearance or approval status of diagnostics for the other analytes on the panel. Read More
In a surprise U-turn, the FDA on Sunday authorized the emergency use of convalescent plasma for treating COVID-19, following accusations by President Trump that the agency was holding off on issuing an Emergency Use Authorization (EUA) for political reasons. Read More
Russia will begin a phase 3 trial of its Sputnik V COVID-19 vaccine on 40,000 volunteers this week, Russia’s state news agency Tass announced Friday. Read More
New data from Gilead Sciences’ late-stage trial of its antiviral remdesivir showed that a five-day course of the drug helped patients with moderate COVID-19 pneumonia, but the finding was of “uncertain clinical importance,” according to researchers. Read More