Draft guidance indicates the regulator is open to using patient experience as criteria for chronic fatigue syndrome treatments.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The draft guidance is mostly procedural, and more guidance is expected, but experts say it does include some long-awaited clarity for advertisers.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.