Topic:
Regulatory
Latest Headlines
Latest Headlines
UPDATED: Arena shares sink after biotech withdraws marketing app for obesity drug in Europe
Arena Pharmaceuticals pulled the plug on its application for approval of the obesity drug Belviq with European regulators, another blow to the commercial and regulatory effort behind the treatment. The San Diego-based biotech revealed the decision to withdraw the app in its first-quarter financial report late Thursday afternoon.
FDA panel rips Delcath drug/device cancer treatment
In what could be a deathblow for Delcath Systems, an FDA panel of experts voted unanimously that the risks of the company's drug-device combo to treat cancer outweighed any benefits.
UPDATED: FDA panel rejects Aveo's kidney cancer drug tivozanib
The committee voted 13 to 1 against Aveo, deciding that the biotech had not produced the needed efficacy data in a single pivotal study. And given the harsh assessment of Aveo from top FDA officials, this is one vote that is not likely to be overturned inside the agency.
China sets rules for excipient makers after scandal
A scandal over toxic drug capsules in China last year brought more unwanted attention to the gap between the country's place in the pharma ingredient world and the ability of its regulators to keep things on the up-and-up.
FDA slaps Class I on Covidien's ventilator battery recall
Last month, Covidien launched a recall of battery packs used with its Newport HT70 ventilators, and now the FDA has assigned its most serious designation to the problem, warning that the malfunctioning batteries could lead to injury or death.
J&J grabs another 'breakthrough' FDA win with early-stage cancer drug
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.
FDA breaks with expert advisers in rejecting Titan addiction med
Agency staffers stuck with the opinions outlined in a harsh internal review and rejected the opioid addiction drug.
Raptor's orphan drug-win at FDA overshadowed by debate over steep price
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.
Amgen blood drugs may help humans survive nuclear attack, FDA says
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.
Hospira pulling the plug on troubled devices
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.
