The FDA slapped a Breakthrough Therapy label on the CLL indication pursuit in February.
The FDA's Center for Drug Evaluation and Research's Office of Communications wants a system that will help assess its messaging reach across the interwebs and its many forums.
It's the second for this cancer drug in two weeks.
The Food and Drug Administration has been intent on elevating and reorganizing its office of Generic Drugs since 2012.
Regulatory Focus reports that the regulator has issued a Warning Letter to AB Science for marketing its canine tumor drug Kinavet for unapproved, off-label uses.
The FDA says the OTC remedy maker's online behavior—including Liking customer Facebook posts—has put the company's drugs in unapproved drug territory.
Boehringer Ingelheim's experimental idiopathic pulmonary fibrosis treatment nintedanib is also an orphan drug.
Researchers from Boston Children's Hospital, Harvard Medical School and Brigham and Women's Hospital are offering a bit of internet advice for the Food and Drug Administration: do more.
The regulator wants men to be part of breast cancer clinical trials.
Phase III results showing improved lung function among cystic fibrosis patients using a combination of Kalydeco and lumacaftor means drugmaker Vertex is filing the two-part drug for FDA approval during the fourth quarter.
Colorado's version of the FDA's compassionate use rule does not sit well with lobbying group Pharmaceutical Research and Manufacturers of America.
The companies resubmitted SGLT2 inihibitor empagliflozen for FDA review. The EC approved the drug in May.
Recent FDA guidelines for health-tracking apps mean Apple's HealthKit, and similar apps, won't have to jump regulatory hurdles before going live.
A coalition of organizations, including pharmaceutical company Sprout, kicked off a campaign urging the FDA to pay as much attention to women's sexual dysfunction needs as it does to men's.
The regulator's latest study will use eye-tracking tools.
The regulator is allocating almost $38 million to improve data-guided decision-making.
The FDA's seven-page letter outlines some of the problems the regulator has with one specific Sun site.
A three-year, $1 million project seeks an equation for generics and biosimilars.
Novartis says the FDA wants more serelaxin efficacy data.
The FDA granted Breakthrough Therapy status to the duo's multiple myeloma treatment.
The regulator defends its approval decision in a web post.
The review includes data the regulator requested about the smoking-cessation drug.
The candidate would be the first to put oxycodone and morphine in one capsule.
The company said it plans to file its rare-disease drug with the FDA later this year, for a 2015 review.
The experimental Breakthrough Therapy treatment is for acute myeloid leukemia.
Poland joins the list of countries in which GlaxoSmithKline is accused of misconduct. Meanwhile, bioequivalence issues have prompted the FDA to revoke its approval of GSK's Wellbutrin generic.
The FDA issued an official halt, five days after Halozyme stopped the Phase-II trial because of patient stroke information.
The FDA has issued draft guidance that funds FDA inspection of some drug compounders.
At a hearing today, Public Citizen and the generics industry are sounding off on an FDA proposal that would allow generics firms to update labels, regardless of whether the brand has or hasn't.
The regulator disputes findings that generic heart drugs made abroad were contaminated.