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The European Medicines Agency has unveiled a new plan for how drug sponsors and regulators should deal with the risk of N-nitrosamine contamination in sartan drugs. Read More
“We are committed to exposing the illicit conduct that took place and holding each of these companies responsible for their role in the opioid crisis,” said the state’s Attorney General Letitia James. Read More
New York’s Attorney General (AG) Letitia James says the Suffolk County State Supreme Court will begin jury selection in January for the state’s trial against multiple opioid manufacturers and distributors for their alleged roles in creating the opioid addiction epidemic. Read More
The FDA has developed two new documents that it wants drug sponsors to use for annual postmarket reporting and is requesting comments on them in a new draft guidance. Read More
AMAG Pharmaceuticals is refusing to withdraw its controversial preterm injection drug Makena from the market and has requested a public hearing with the FDA hoping to reverse the agency’s call for the drug’s withdrawal. Read More
Johnson & Johnson (J&J) has agreed to contribute an additional $1 billion to resolve multiple opioid lawsuits over its alleged role in the opioid addiction crisis at the state, city, county and tribal level. Read More
The FDA is calling for AMAG Pharmaceuticals to withdraw its preterm birth injection Makena (hydroxyprogesterone caproate), as well as its generics, from the market after a postmarket study failed to demonstrate efficacy. Read More
Sanofi and GlaxoSmithKline announced in Security Exchange Commission (SEC) filings that the Department of Justice and the U.S. Attorney’s Office for the Eastern District of Pennsylvania have opened an investigation into their reporting of potentially contaminated Zantac (ranitidine). Read More