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 Therapeutic Goods Administration is considering adopting 15 EU guidelines relating to drug development, including guidance on biosimilars, lipid disorder therapies and bacterial infections. Read More
Indian generics maker Ranbaxy will pay $2.3 million for selling drugs in Oregon that were manufactured in violation of current good manufacturing practices. Read More
French drugmaker Servier and five generics firms are facing roughly $580 million in fines from European antitrust regulators over an alleged pay-for-delay scheme. Read More
The European Medicines Agency acted properly in rejecting a UK-based pharmaceutical company’s over-the-counter migraine medicine, the European ombudsman says. Read More
The generic drug industry wants the FDA to ensure new requirements for packaging and technologies aimed at curbing opioid abuse don’t result in barriers to market entry for generic makers. Read More
European drugmakers are praising the European Commission’s plans to increase enforcement of intellectual property rights in the EU and developing world over the next two years, saying they are important to ensuring EU innovation and economic competitiveness. Read More
The FDA is seeking a permanent injunction against a California drugmaker, saying the company manufactures and distributes over-the-counter vaginal products without proper regulatory approval. Read More
The FDA would require biosimilars to carry the same name as their reference drug counterparts under a proposal being pushed by healthcare payers and GPhA. Read More
The FDA is renewing the call for nominations for the list the agency is building of active drug substances that can be used to compound drug products, saying many of the responses to its December effort to build the list were inadequate. Read More