Months ahead of its priority review PDUFA date, Calquence (acalabrutinib) got the FDA's green light Tuesday as a second-line therapy for adults with mantle cell lymphoma.
Serving as a cautionary tale for other drug companies, Insys Therapeutics Inc. is trying to right its ship after John Kapoor – its founder, former CEO and majority owner – was arrested last week on federal racketeering and fraud charges related to the off-label distribution of Subsys, a fentanyl spray approved for cancer patients with breakthrough pain.
Calling it a "human tragedy," a "terrible affliction" and a "national shame," President Donald Trump officially declared the U.S. opioid epidemic a national public health emergency Thursday.
U.S. Democratic lawmakers delivered on a long-touted promise Wednesday as they introduced legislation to allow Medicare to directly negotiate Part D prescription drug prices. Now they're calling on President Donald Trump to keep his promise to support Medicare negotiations.
If Puerto Rico's power grid isn't restored by the end of the year, many of the drug and device companies with manufacturing facilities there may need to relocate some of their production, FDA Commissioner Scott Gottlieb told a House subcommittee Tuesday.
Another congressional hearing on drug prices yielded a familiar clanking about importation, direct Medicare negotiation and transparency, transparency, transparency.
In a precedent-setting decision Thursday, the U.S. Court of Appeals for the Federal Circuit granted Sanofi SA and Regeneron Pharmaceuticals Inc. a do-over of sorts on whether their cholesterol drug Praluent infringes Amgen Inc.'s patent claims for antibodies targeting PCSK9.
An FDA advisory committee made history Thursday with its unconditional support for Spark Therapeutics Inc.’s Luxturna, which is on track to become the first gene therapy to be approved in the U.S. to treat an inherited disease.