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.
Beleaguered Indian generics maker Wockhardt is recalling 109,744 bottles of the hypertension drug metoprolol due to problems with how the product dissolves in the body. Read More
The European Commission is mandating that drugmakers implement a detailed protocol for transferring testing methodology from one lab to another to ensure product quality. Read More
Canadian drug regulators have temporarily banned Biolyse Pharma from making and selling its cancer-fighting agent paclitaxel after a series of inspections at the firm’s St. Catharines, Ontario, facility uncovered serious manufacturing problems. Read More
The FDA slapped Blue Ridge Pharmacy and Compounding Center with a warning letter for compounding products without a prescription and poor conditions for aseptic processing, another sign that the agency doesn’t plan to let up on large compounders. Read More
European and U.S. regulators have made strides towards mutual recognition of quality inspections so that companies being inspected by one regulator would not have to face an inspection by the other, but setbacks still remain, a top European regulatory official said. Read More
Takeda scored a legal victory last week when an Illinois jury found the drugmaker wasn’t responsible for a man’s death while he was on the diabetes drug Actos. Read More
Injectable drug maker Hospira has issued a voluntary recall of dobutamine injection, USP, after a customer complaint of discoloration in a single vial of the heart disease drug. Read More
The FDA has rejected Novartis’ heart drug Reasanz due to minimal data on efficacy, the latest regulatory setback for the experimental treatment. Read More
The FDA blasted generic drugmaker Alvogen for a promotion of the alcoholism treatment disulfiram that omitted potentially life-threatening risks. Read More