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With dozens of clinical trials of hydroxychloroquine as a COVID-19 treatment currently in the planning or enrollment stages, there are mounting concerns that the drug’s risks could outweigh the benefits for COVID-19 patients. Read More
The FDA said sponsors of emergency-use injectors should include details in their marketing applications to show that the devices are reliable. Read More
Rick Bright, the ex-director of HHS’s Biomedical Advanced Research and Development Authority (BARDA), said yesterday that he was removed from his post because he pushed back against the administration’s promotion of two anti-malaria drugs to treat COVID-19. Read More
A federal appeals court has ruled that Banner Life Sciences may make and market its version of Biogen’s blockbuster multiple sclerosis drug, Tecfidera (dimethyl fumarate). Read More
The FDA hit online pharmacy Unitedpharmacies.md with a warning letter for marketing on its website unapproved and misbranded products as COVID-19 treatments. Read More
The director of HHS’ Biomedical Advanced Research and Development Authority (BARDA), Rick Bright, has departed from the federal vaccine development agency to helm a new initiative on COVID-19 diagnostics at the National Institutes of Health (NIH). Read More
The FDA’s Coronavirus Treatment Acceleration Program is gearing up for a second wave of potential COVID-19 treatments and vaccines as the search for effective products gains momentum. Read More
The United Nations adopted a resolution calling for pharma companies to waive exclusive rights for their vaccines and treatments during the COVID-19 crisis. Read More