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.
General support for the legislation is up, despite Healthcare.gov woes.
Sebelius took the heat for Healthcare.gov, promising that most people would be able to shop for coverage online by November.
The agency made good on a pledge to expand Bad Ad with a web-based CME course and case studies representing common problems.
The American Medical Association (AMA), together with a slew of co-signers, wants CMS to reverse a decision to include textbooks and journal reprints as reportable items.
It was a 15-0 vote for Gilead's sofosbuvir in hep. C. The expedited PDUFA date: Dec. 8. Janssen's simeprivir was endorsed the day before.
The hep. C drug is safe and effective when used in combination with other therapies, according to information posted by FDA reviewers.
Adding Epzicom to Tivicay in a once-daily cocktail could further boost GSK's HIV franchise, and possibly chip away at Atripla's dominance.
The governor says it is too early to legislate on drugs the FDA is still deliberating over.
The drug maker is giving its inhaled insulin another go.
Approvals and reviews continue—for now—despite government shutdown.
A public information request details closed-door meetings in which industry players paid to sit with government employees and talk pain-medication efforts.
A roundup of some exchange-related news circling the web.
The agency issued final guidance on mobile apps, saying it will focus only on a subset that present the greatest risk to patients if they don't work correctly.
How potential alignment between drug companies and physicians, via the EHR, could extend brand reach.
Researchers says growth will average 5.8% a year between 2012 and 2022. They also anticipate generics will hit a leveling-off point that will drive average Rx prices upwards
Some providers of CME are getting better at complying with accreditation criteria, data show, yet many are still struggling to meet a stricter set of requirements.
The changes, which include tightening prescribing criteria of extended-release and long-acting opioids and a boxed warning for pregnancy, are part of an effort to curb abuse. Some said the FDA's effort is too limited
The FDA and Novartis are investigating reports that a patient has contracted the rare virus.
The drugstore chain says it has cut off over-prescribers of tightly controlled medications.
The drug maker scored its third breakthrough designation label, this time for orphan drug bimagrumab, a possible treatment for a muscle-wasting disease.
FDA's Office of Prescription Drug Promotion issued an Untitled Letter over what it says are misleading copy and overstated efficacy claims online.
HHS is looking into how J&J marketed opioid painkiller Nucynta, adding to the firm's list of investigations and those of the industry as a whole.
GSK sees a regulatory setback on its once-weekly GLP-1 med, and Spectrum Pharma gets hit with an untitled letter from OPDP on a sales aid for Zevalin.
The ad watchdog flagged the drug maker for what it said was yet another misleading Ampyra promotional piece.
With a new era of transparency for doctors and life science manufacturers kicking off today, here's how some organizations are keeping physicians informed.
Companies are moving toward more access to clinical trial data. Despite their new stance, the internal battles haven't quite ended, some say.
A report indicates that the FDA is siding with the European Medicines Agency's finding that GLP-1 diabetes medications are not conclusively linked to pancreatic cancer.
A new survey of doctors reveals how much they know (or don't) about the looming launch of healthcare exchanges.