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.
Variations in right-to-try laws passed in multiple states and at the federal level could mean compliance headaches for companies taking part in expanded access. Read More
The European Medicine Agency’s safety committee is recommending labeling changes for several products to cover newly identified risks of adverse events and side effects. Read More
Former FDA commissioner Mark McClellan has put forward a proposal for value-based pricing of antimicrobials, and pricing experts tell FDAnews it has potential. Read More
The FDA failed to follow federal law when it refused to provide exclusive marketing rights to United Therapeutics for its treprostinil formulation, branded as Orenitram, as an orphan drug, the company said in a federal lawsuit. Read More