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The FDA has slapped Eosera with a Form 483 after finding the over-the-counter (OTC) ear-care product manufacturer failed to validate drug products and properly investigate bacterial contamination. Read More
Acadia Pharmaceuticals’ Nuplazid (pimavanserin) failed to meet its primary endpoint in two phase 3 clinical trials evaluating it for major depressive disorder. Read More
Clinical research on human drugs that contain cannabis can be conducted legally as long as the amount of the substance in the investigational product is within limits set by a new FDA draft guidance. Read More
The Department of Justice announced yesterday that two Chinese hackers have been indicted on charges of trying to hack COVID-19 vaccine research in the U.S. Read More
As a result of the COVID-19 pandemic, the FDA has extended its enforcement discretion policy for six months for manufacturers of stem cell products to submit marketing applications to the FDA. Read More
Based on the results of a phase 2 trial, UK-based Synairgen said Monday that its antiviral SNG001 reduced the risk of severe disease in hospitalized COVID-19 patients. Read More
The British government announced Monday that it has reached COVID-19 vaccine supply deals with Pfizer/BioNTech and Valneva, locking in tens of millions of doses of their vaccine candidates for the country. Read More