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’s program alignment will see district offices and laboratories focus only on one category of products, primarily designated by geographic location and the types of industries that surround those locations, FDA Acting Commissioner Stephen Ostroff said. Read More
In an effort to ease a major generics approval backlog, the FDA is advising generic drugmakers and regulators on how best to streamline ANDAs of varying strengths into a single application. Read More
In an effort to ease a major generics approval backlog, the FDA is advising generic drugmakers and regulators on how best to streamline ANDAs of varying strengths into a single application. Read More
The FDA and European Medicines Agency took differing views on multiple melanoma injections up for approval, with the U.S. agency rejecting Spectrum Pharmaceuticals’ Evomela and the EMA’s scientific experts recommending approval of Amgen’s Imlygic. Read More
The FDA Friday approved Alexion Pharmaceuticals’ Strensiq for the first-ever treatment of hypophosphatasia, a rare genetic metabolic disorder that weakens bones. Read More