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Citing a substantially increased volume of requests for expanded access to investigational drugs to treat COVID-19, the FDA has issued a final guidance that clarifies the conditions under which it will consider sponsor and investigator requests for waivers from full IRB review. Read More
Researchers in the UK are launching a clinical trial to test a unique formulation of ibuprofen for treatment of severe acute respiratory distress syndrome (ARDS) in COVID-19 patients. Read More
Several common cardiovascular drugs are being studied as potential COVID-19 treatments, with early findings suggesting they pose no increased risks for patients taking them regularly. Read More
Two respected medical journals have raised questions about the reliability of data provided by a controversial data analytics company in two different trials done for two COVID-19 treatments. Read More
The University of Minnesota has published results from its COVID-19 hydroxychloroquine trial that show the anti-malaria drug is ineffective at preventing coronavirus infection, echoing negative results from other recent studies. Read More
The Trump administration has reportedly selected five COVID-19 vaccine candidates from a list of 14 to be evaluated under Operation Warp Speed. The five frontrunners are being developed by Moderna, Johnson & Johnson, AstraZeneca, Merck and Pfizer. Read More
The FDA cited active pharmaceutical ingredient (API) manufacturer Abbey Color for failing to properly qualify its suppliers and other quality lapses at its Philadelphia, PA facility. Read More