Eight months after Johnson & Johnson committed to a $1.1 billion deal package to partner on Genmab's cancer antibody daratumumab, the FDA has blessed the Phase I/II program with its new "breakthrough" designation.
Agency staffers stuck with the opinions outlined in a harsh internal review and rejected the opioid addiction drug.
Raptor Pharmaceutical has scored an FDA approval of its new drug for a rare metabolic disorder. But the steep, 6-figure price tag being put on the drug, Procysbi, is already drawing flak from a growing contingent of analysts who wonders just how much drug developers can command from payers for rare-disease drugs before a backlash occurs.
Here's a story that takes us back to our Cold War childhood. Two of Amgen's blockbuster blood drugs, Neulasta and Neupogen, may help victims survive after a nuclear attack, FDA staff reviewers say.
After a year of recalls, bans and technical failures, Hospira is changing the way it does business in medical devices, planning to discontinue some of its infusion pumps and focus on next-generation technology.
Medical device maker Cardiovascular Systems confirmed that the U.S. government has requested information as part of an investigation into corporate insider investment vehicles.
All the bipartisan agreement on repealing the medical device tax would suggest a short life for the 2.3% charge, but that's not quite how Washington works. Read more >>
In the end, a vote by an outside panel of FDA experts favoring approval of Titan Pharmaceuticals' Probuphine didn't influence the outcome at all.
In a move that appears to be testing the waters, the FDA on Thursday approved Plan B One-Step emergency contraception for sale to girls and women ages 15 and older without a prescription, and said it no longer could be kept behind the counter.
Delcath Systems' cancer-drug delivery device suffered a hitch as the FDA said the associated risks likely outweigh any benefit.