Danish police are investigating the drugmaker over its decision to wait two days before announcing the FDA's February rejection.
FDA panel briefing documents indicate concern remains over bladder cancer, as the drug dapagliflozin undergoes a second review Thursday.
Reports of a Dec. 5 deal between the US and China could deepen inspectors' reach.
The drug is priced at $28,000 a month, before add-ons like ribivarin and (possibly) interferon.
Phase-IIIb study results indicate Lyxumia—which is approved abroad but not in the US—was "non-inferior" in terms of controlling blood sugar levels regardless of whether the shot was given before breakfast or later.
The agency extended the review time for Biogen's Alprolix by three months.
Critics worry the talked-about approval plan could mean adverse events surface far too late.
The marketing watchdog's untitled letter says a direct mailer failed to disclose "material facts" from the warnings and precautions section of the PI.
Regulators say the company has not received approval for the device's touted functions.
The patient population is small, at around 3,000, but the expected price tag is $330,000 a year.
The agency says mobile traffic has more than doubled over the past 12 months.
EyeonFDA finds that, when it comes to black-boxed drugs' marketing materials, the FDA is more likely to issue Warning Letters than untitled letters.
Reviewers supported the drug's approval, but concerns about REMS and clinical trial integrity indicate the vote was not a roaring endorsement.
The company also has breakthrough therapy designations for CLL and Waldenstrom's macroglobulinemia.
A report says this year's approvals could be worth more than last year's, even though the number of approvals will be fewer.
Most patients would advise today's FDA Lemtrada panel to allow doctors to gauge the drug's risk-benefit profile, although there was strong sentiment on either side of the issue.
The regulator says the drugmaker needs to do more testing.
The drugmaker's latest financial plans could power it through mid-2015.
The company announced the layoffs Friday.
The proposed change would allow generics makers to update labels even if branded drugmakers do not, possibly opening up generics to new liability issues.
Safety reviewers' reservations about the MS drug's risk profile, unveiled in briefing documents ahead of an ad-com meeting, suggest it won't be smooth sailing for the drug in the US.
The regulator has rescheduled two advisory committees cancelled during the government shutdown.
The regulator approved the CLL medication Friday, giving the drugmaker time to create a marketing transition before Rituxan goes generic. The approval marks another milestone: the first drug approved with a Breakthrough Designation label, a tag that is now coming under scrutiny.
The drug company is ceasing US distribution and marketing the leukemia drug after the FDA said it was worried about blood clots among clinical trial patients.
The regulator will study how teens perceive ads and if targeted media needs unique standards.
The FDA told the drugmaker in a letter before the December PDUFA date that evidence does not support an expanded indication.
A court refuses to compel a government agency to schedule the firm's epilepsy drug, as the med's patent clock ticks.
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.
Researchers say it's not just payers supporting the switch, and all ages appear to be brand agnostic.