Tag Archives: FDA’s

FDA’s new JAK safety restrictions spell trouble for AbbVie’s Rinvoq, but to what extent?

AbbVie’s megablockbuster Rinvoq ambition suffered a blow thanks to an updated safety warning and treatment restriction from the FDA. But pharma watchers have different opinions on just how significant the impact will be on AbbVie’s JAK inhibitor. In an announcement Wednesday, the FDA is revising Rinvoq’s boxed warning to include information about increased risks of… Read More »

Sprout’s female libido drug Addyi back in FDA’s crosshairs years after controversial approval

Sprout Pharmaceuticals’ female libido drug Addyi has traveled a winding path through FDA gatekeepers, multiple M&A deals, marketing restrictions and more. With a possible new safety flag, the controversial medicine could be set for even more scrutiny. In a rundown of potential new safety concerns on approved products, the FDA flagged the Addyi for possible risks of drug hypersensitivity.… Read More »

FDA’s inspection woes to grow if agency doesn’t address COVID-19 backlog: GAO

The Government Accountability Office has concerns about the FDA’s widening inspection backlog. COVID-19 certainly amplified the problem, but the issues had been mounting long before last March. As the FDA looks to honor lockdown rules and protect its staffers, the agency has largely paused inspections since the pandemic started last spring, conducting only those deemed “mission critical.”… Read More »

Viewpoints: Doctors Need To Stop Saying No To Patients Who Need Opioids; FDA’s E-Cigarette Policies Could Make It Tough On U.S. Troops

Opinion writers weigh in on these health topics and others. Bloomberg: Prescription Drugs Aren’t To Blame For Rise In Addiction Deaths Patients in pain have become collateral damage in the war on opioids. That’s the message of a letter from more than 300 medical professionals, including three former White House drug czars, to the Centers… Read More »