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The FDA hit a La Habra, California compounding pharmacy with a warning letter for repeated violations, including dirty equipment and the presence of insects. Read More
Inovio Pharmaceuticals has released data from the phase 1 clinical trial of its COVID-19 vaccine candidate showing it was safe and well-tolerated and induced immune responses in a majority of participants. Read More
The University of Oxford is resuming recruitment this week for its global clinical trial of hydroxychloroquine and chloroquine, which was paused after a now-retracted study found the antimalarial drugs had no benefit as a treatment for COVID-19. Read More
FDA Commissioner Stephen Hahn said yesterday that he was “optimistic” that more than one COVID-19 treatment could be available by the fall in addition to Gilead Sciences’ remdesivir, which has already received Emergency Use Authorization from the agency. Read More
Any COVID-19 vaccine the FDA approves would have to be at least 50 percent more effective than a placebo, according to a new guidance it released yesterday. Read More
The FDA cited USV Private for multiple violations at its drug manufacturing facility in Daman, western India, including invalidating out-of-specification (OOS) results without any justification. Read More
The FDA will allow sponsors to extrapolate efficacy results from adult studies to use in pediatric studies of anti-infective drugs, as long as the disease process and the effects of the drug are similar in both populations. Read More
The FDA issued Intercept Pharmaceuticals a complete response letter for its investigational drug, obeticholic acid (OCA), for liver fibrosis due to nonalcoholic steatohepatitis (NASH). Read More
The University of Oxford is ready to launch a phase 3 trial in Brazil of AstraZeneca (AZ)’s COVID-19 vaccine candidate, considered by the World Health Organization (WHO) to be the frontrunner in the research race. Read More