Upcoming events in the coming weeks include seven FDA advisory committee meetings as well as the the GMP Quality Management vSummit, the WCG MAGI@Home Clinical Research Conference 2023, and a…

Amgen and Horizon have launched a return volley in their battle with the FTC, asking the U.S. District Court of Northern Illinois to deny the FTC’s July motion that sought…

In a recent court filing, HHS lambasted the U.S. Chamber of Commerce’s recent call to slow down implementation of pricing negotiations within the Inflation Reduction Act (IRA), calling the group’s…

This first European Edition of Quick Notes includes a PDUFA date extension for a chikungunya vaccine candidate, NICE approved AI technologies for radiotherapy treatment therapies, Novartis cited for claims made…

The FDA has classified the most recent recall of certain Philips Trilogy ventilators as class I, the most serious type of recall as use of the device may lead to…

Incorporating off-the-shelf (OTS) software into medical devices is becoming more common but a new guidance from the FDA advises that when using prepared software from another manufacturer, devicemakers still bear…

Illumina received notice in July that the Securities and Exchange Commission (SEC) was conducting an investigation into the company’s acquisition of Grail, requesting documents from the company over the beleaguered…

Oncopeptides is appealing a formal request from the FDA to withdraw its blood cancer therapy drug Pepaxto (melphalan flufenamide) as the agency flexes its newfound regulatory authority for pulling drugs…

PhRMA, the National Infusion Center Association and the Global Colon Cancer Association have filed a motion for summary judgment — a final decision made by a judge without going to…

More than 60 percent of the drugs approved last year won their FDA nod on the basis of a single clinical trial that was conducted by the drug sponsor, a…