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Colombia’s Ministry of Health and Social Protection announced its plans to unilaterally cut the price of Novartis’ myeloid leukemia treatment Gleevec after negotiations with the Swiss drugmaker fell through the cracks. Read More
The FDA has a slate of new recommendations companies should follow when submitting a comparability protocol assessing changes to the chemistry, manufacturing or controls of a drug or biologic after the agency has approved its production process. Read More
In response to a slew of warning letters regarding data integrity issues, the FDA is addressing questions on the matter that have come up in recent inspections. Read More
The FDA and other international regulators and law enforcement agencies have joined forces to crack down on illegal online drug distributors, requesting the suspension of 4,402 websites that sell illegal and potentially counterfeit products to U.S. consumers. Read More
An FDA advisory committee recommended the approval of Merck’s bezlotoxumab to prevent Clostridium difficile infection recurrence in patients 18 and older. Read More
The FDA has handed Boehringer Ingelheim a 10-observation Form 483 for delays with a field alert report, as well as sanitation and sterilization procedures at a site in Germany. Read More