The historic 2023 approval of OTC naloxone was a highlight of the FDA’s efforts to combat the opioid overdose crisis, according to CDER’s year-end report on drug safety actions. Source:…

Despite its denial of any wrongdoing, Pfizer has agreed to a settlement payment of $93 million to finally erase 12 years of antitrust litigation with drug distributors involving Lipitor, the…

Senate Majority Whip Dick Durbin (D-Ill.) and Senator Mike Braun (R-Ind.) have urged the FDA to take “swift” action to update its enforcement tools to address the alarming proliferation of…

Over the past week, the FDA issued a final rule on BLAs and master files. Final Guidance was issued on charging for investigational drugs under an IND. Draft guidance was issued…

The Dayton Chamber of Commerce doesn’t represent any of the pharmaceutical giants affected by the drug negotiation provision of the Inflation Reduction Act (IRA), HHS says in its motion to…

The FDA has issued final guidance on charging for investigational new drugs in clinical trials, offering a minor update to its recommendations. In addition, the agency has published new draft…

This week, your watch can start alerting you to sleep apnea, a fingertip clip can monitor your daytime blood oxygen, and a robotic exoskeleton can help restore mobility to spinal…

The presentation and accuracy of medical information through traditional and social media — and even the headlines that accompany it — directly impact the nation’s health, FDA Commissioner Robert Califf…

The FDA has deemed Smiths Medical’s recall of its Medfusion model 4000 syringe pump as Class I for software issues that can make the pump fail and delay or interrupt…

With the composition, practice and utilization of data monitoring committees (DMC) changing considerably over the years, the FDA has published a new draft guidance on their use in clinical trials…