The experimental Breakthrough Therapy treatment is for acute myeloid leukemia.
Facts tucked among the 9.2 million lines of data: 2% of doctors account for around 25% of Medicare billing.
The regulator has put off the inhaled insulin's PDUFA date by three months.
The ACA has spurred double-digit increases in demand for pharmaceuticals, new data suggest.
The FDA has issued draft guidance that funds FDA inspection of some drug compounders.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 Bay State is saying no to the controversial prescription painkiller.
Longtime industry critic, Congressmen Henry Waxman penned a note to Gilead CEO over the "extraordinarily high cost," of its recently approved HCV treatment Sovaldi.
A rival's late-stage trial results suggest the pain med may have a short market life. The key: an FDA division head's documented willingness to overturn the approval should another pain option surface.
Around 25% of 18-34 year-olds have signed up for coverage. Obama's FunnyorDie appearance drives HHS traffic.
The FDA's bad-ad unit took a drugmaker to task for what it calls a misleading Facebook page. History shows the social media surveillance should take no one by surprise.
Draft guidance indicates the regulator is open to using patient experience as criteria for chronic fatigue syndrome treatments.
The agency's move to limit the formulary for certain drug classes is dead.
Sanofi and the firm with which it's co-developing alirocumab disclosed that regulators want some patients to be assessed for neurocognitive side effects.
The FDA's proposed upgrade to its off-label distribution guidelines has some new features, but experts say it is unclear if this means more dollars will flow toward reprints.
After a wave of feedback, the accreditor has deferred a ban on use of corporate logos in disclosures of commercial support.
Innovator companies want the FDA to adopt separate names for biosimilars. Manufacturing changes aren't drastic enough to make it necessary, experts argued at an FTC workshop.
A report indicates pharma companies do not agree on what research needs to be reported.
The draft guidance is mostly procedural, and more guidance is expected, but experts say it does include some long-awaited clarity for advertisers.
The MS pill saw rapid uptake in the US last year, but its overseas launch won't be as quick, CEO George Scangos conceded this week at an analyst conference.
Our year-end list captures the 10 that sparked heaviest interest.
The accreditor wants comments on its new accreditation plan, but a new commendation proposal is yet to come.
The firm has vowed to appeal an FDA rejection that otherwise complicates its bid to expand in multiple sclerosis.
The FDA approved Orenitram (treprostinil), after rejecting it twice before.
Kalydeco failed to hit its primary endpoint of significantly improving lung function in a subset of CF patients, but some did show a benefit.
Teva said a settlement will allow it to sell a copy of the blockbuster ED pill prior to the official LOE.
The regulator tells farmers to limit antibiotic use.
The government division is scrutinizing marketing information for three drugs.
The agency extended the review time for Biogen's Alprolix by three months.
Official numbers are pending, but Reuters notes enrollment appears to be just 3% of the government's goal.