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.
A federal judge dismissed more than 40 states’ claims against the parent company that manufactures Suboxone in a suit accusing it of suppressing generics. Read More
The FDA published a draft guidance explaining the new GDUFA fee structure and the types of fees that took effect Oct. 1. The draft also covers how to submit payments to the agency, the consequences for failing to pay, and how to request reconsiderations of user fee assessments. Read More
John Kapoor, founder and majority owner of Insys Therapeutics, was arrested and charged with bribery and fraud in the illegal distribution of a fentanyl spray, an opioid intended to treat pain in cancer patients. Read More
President Donald Trump officially declared the nationwide opioid crisis a public health emergency Thursday, directing agencies to use existing authority to the best of their ability to combat the epidemic. Read More
FDA Commissioner Scott Gottlieb told lawmakers the agency will work to break the stigma associated with medication-assisted treatments for opioid dependence and addiction. Read More
Medicare administrators could negotiate lower prices with drug companies, potentially saving the federal government billions of dollars a year, under legislation House and Senate Democrats are introducing in Congress. Read More
The FDA continues to work to restore drug manufacturing crippled by hurricane Maria in Puerto Rico, with special response teams set up to tackle the job, but none of the plants has reached 70 percent of its pre-storm capacity, FDA Commissioner Scott Gottlieb told a congressional committee. Read More
Over the past month, Boehringer Ingelheim has sued five manufacturers seeking to produce generic versions of the company’s Gilotrif lung cancer treatment — most recently naming Sandoz and Sun Pharmaceutical. Read More
An Atlanta federal judge found several individuals and their two firms in contempt for violating court orders over the sale of deceptively marketed weight-loss supplements, imposing a judgement of more than $40 million. Read More