The U.S. Food & Drug Administration declined to approve two China-tested cancer treatments on Monday, saying one of the companies – Hutchmed Ltd. – needs to test its drug for the U.S. population in a diverse multi-regional trial.
U.S. FDA Advisers to Discuss Additional COVID Vaccine Boosters
BNT162b2 (Pfizer and BioNTech), Coronavirus Disease 2019 (COVID-19), Coronavirus Disease 2019 (COVID-19) Reinfections, COVID-19 booster shots, COVID-19 shots, COVID-19 Vaccines, FDA, FDA Statements, FDA/Regulatory, mRNA-1273/Moderna COVID-19 Vaccine (Moderna), Omicron (B.1.1.529) (South Africa), Research & Development, Therapeutics, VaccinesThe U.S. Food and Drug Administration’s expert advisers will discuss the timing of additional COVID-19 vaccine boosters and the people eligible for the extra shots in a meeting later this week, the health agency said on April 4.
The U.S. Food and Drug Administration published a “Statement on Leronlimab,” CytoDyn’s monoclonal antibody that was initially being developed for HIV and cancer before the company began testing for Covid-19. In an unusual public scolding, the regulatory agency accused CytoDyn of misrepresenting clinical trial results for the drug in Covid-19.