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.
KemPharm has appealed the FDA’s complete response letter for its opioid Apadaz, contending that the company’s clinical evidence merits an approval with abuse-deterrent claims. Read More
Prospects look somewhat grim for the life sciences industry in the UK, regardless of whether the country decides to completely divorce itself from the EU or do a “soft exit,” a think tank says. Read More
Endo Pharmaceuticals is pushing to keep alive a lawsuit against it by the Federal Trade Commission in the U.S. District Court for the Eastern District of Pennsylvania. Read More
Australia’s Therapeutic Goods Administration is proposing expedited drug application reviews that would mirror programs in North America and Europe. Read More
The European Medicines Agency is investigating reports that India’s Wanbury Pharma, one of the largest exporters of the diabetes drug metformin, had more than half of its exports produced by an unlicensed supplier. Read More