We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
After weeks of waiting, Gilead Sciences announced yesterday that it will charge U.S. insurers $3,120 for a six-vial, five-day course of remdesivir, and a lower price of $2,340 for governments of developed countries, including the U.S. Read More
Novartis has agreed to pay $345 million to the U.S. government to settle charges that it violated the Foreign Corrupt Practices Act (FCPA) by bribing doctors in Greece and Vietnam. Read More