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.
Drug giant AstraZeneca has scored a big win in Europe, reeling in marketing authorization for Zurampic for patients with gout and a new dose of the heart medication Brilique. Read More
The FDA is offering more information on trial designs for sponsors developing therapies to treat allergic and nonallergic rhinitis and anthrax exposure. Read More
The FDA has slapped India’s Cadila Pharmaceuticals with a warning letter for GMP violations — including a lack of quality controls, improper recordkeeping and inadequate investigations — at its Moraiya formulation plant and Ahmedabad API facility. Read More
A federal appeals court has ruled that Caraco Pharmaceutical Laboratories’ assumption that its plants wouldn’t be closed for GMP violations was not legal justification for it to skirt layoff-notice labor laws. Read More
The UK’s National Institute for Health and Care Excellence delivered a stinging rebuke to Alexion Pharmaceuticals, saying it would not reimburse Kanuma for the treatment of lysosomal acid lipase deficiency until more evidence could support it. Read More