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 is planning studies on whether drugmakers are effectively conveying the risks associated with a drug when benefit claims about the drug are made online in character-space-limited communications. Read More
The FDA’s Office of Prescription Drug Promotion is ordering Supernus Pharmaceutical to stop making misleading claims about the use and risks of Oxtellar XR. Read More
An FDA advisory committee has narrowly backed the approval of Cempra’s antibiotic Solithera for the treatment of community-acquired bacterial pneumonia, despite raising concerns about the candidate’s safety profile and study sample size. Read More
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