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February 23, 2021
New data shows that the COVID-19 vaccines can be stored at standard freezer temperatures for up to two weeks.
February 22, 2021
The agency issued guidance for developers of vaccines, diagnostics, and therapeutics to address variants of the COVID-19 virus.
February 19, 2021
FDA issued a public statement and press release, along with a sharp warning letter rebuking AcelRx Pharmaceuticals for its messaging on painkiller Dsuvia.
February 17, 2021
The European Medicines Agency announced it has started a review of drugs that contain amfepramone due to concerns that include heart problems and high blood pressure in the lungs.
FDA published recommendations on the use of COVID-19 convalescent plasma or investigational convalescent plasma during the pandemic.
February 15, 2021
The company has pleaded guilty to violating the Federal Food, Drug and Cosmetic Act by failing to provide certain records to FDA investigators and will pay a criminal fine of $30 million, and forfeit an additional $20 million.
February 12, 2021
Scientists and policy makers are looking more sharply at the lag in identifying and producing medicines to moderate early infections and to treat seriously ill patients.
February 11, 2021
The EUA is based on positive results from a Phase III trial that showed bamlanivimab and etesevimab together reduced the risk of COVID-19 hospitalizations and death by 70%.
February 10, 2021
The cell therapy will be manufactured for each individual patient at BMS’ immunotherapy manufacturing facility in Bothell, WA, and will be launched across a network of treatment centers.
The selection of a new FDA commissioner has become a contentious issue in Washington, as the White House delays a decision and interest groups line up behind competing candidates.