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.
An FDA advisory committee voted 12-to-1 against recommending approval of Janssen’s Plivensia (sirukumab) in treating rheumatoid arthritis, saying its safety profile raised too many concerns. Read More
A California company violated federal law by making and selling as a dietary supplement a product containing prescription drugs used to treat erectile dysfunction, the FDA said. Read More
The European Medicines Agency developed a continuity plan to handle the workload linked to the UK’s withdrawal from the European Union and the relocation of the EMA’s headquarters. Read More
Drug companies must ensure their products meet federal standards for child-resistant packaging before labeling the packaging as child-resistant, the FDA said in draft guidance issued Aug. 2. Read More