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The FDA last month warned a Chinese active pharmaceutical ingredient (API) maker for data integrity violations, marking the agency’s 13th warning letter to cite data integrity out of 18 overall warnings released in 2014 for quality violations. Read More
Actavis must keep its Alzheimer’s drug Namenda on the market for now, but a recent agreement with the New York Attorney General will let the company avoid notifying more than half a million people of that fact. Read More
Vertex Pharmaceuticals’ cystic fibrosis drug Kalydeco has won FDA approval for an additional indication to treat patients six years and older with at least one copy of the R117H gene mutation. Read More
The FDA approved Hospira’s nonsteroidal anti-inflammatory drug (NSAID) analgesic Dyloject to treat mild to moderate pain as well as moderate to severe pain either on its own or in combination with opioid analgesics. Read More
India has finalized the formulas that drugmakers must use to determine compensation for patients who are injured while in clinical trials, but one expert says the move will do little to attract industry back to the country to conduct trials. Read More
Genentech bolstered its case that Gazyva is more effective at treating front-line leukemia than the company’s older drug Rituxan, which is set to face stiff biosimilar competition in a few years. Read More
The FDA has warned a Mississippi compounder for not disinfecting its clean room equipment and for other serious manufacturing violations, capping a busy year for the agency’s compounding pharmacy enforcement. Read More
The FDA on Monday published 28 new product-specific guidances and revised testing recommendations on another 15 therapies to aid ANDA filers in designing bioequivalence studies for their applications. Read More
The FDA has pledged to delay enforcement of key elements of its new track and trace regulations for drugmakers, promising that until May 1 it will take no action against companies that do not capture and transmit product information. Read More