Tucked away in the Federal Register are the FDA's intentions to test its own labeling format to "inform FDA's planned regulatory approach to standardizing medical device labeling across the United States."
The FDA approved a new opioid-induced constipation treatment from partners AstraZeneca and Nektar Therapeutics, shaking off some safety concerns and green-lighting a drug the two hope can bring in billions.
Next month, the FDA's expert advisers will take another look at Pfizer's stop-smoking drug Chantix. The official agenda: Weigh new data on Chantix's links to psychiatric side effects, and consider changing the black-box warning about those risks.
A court ruling has saddled biodefense specialist Siga Technologies with debts it cannot pay, the company said, and the biotech is filing for bankruptcy in an effort to keep its doors open long enough for an appeal.
Some analysts called it a cheap trick when Forest Laboratories said it would stop making the Alzheimer's drug Namenda this fall so it could push patients to switch to their new long-acting version as generic rivals to the original loom. New York attorney general Eric Schneiderman calls the tactic something else: illegal.
Novo Nordisk bolstered its better-late-than-never case to win FDA approval for a new long-acting insulin, as the drug, Tresiba, met its main goals in a study on children with Type 1 diabetes.
Anxious to prove that U.K. drug regulators aren't as slow and stodgy as they're often accused of being, British officials today announced the first in a new category of experimental drugs to earn the title of "Promising Innovative Medicine."
Two years after safety concerns torpedoed their first pitch, partners Baxter and Halozyme Therapeutics have locked up FDA approval for HyQvia, a treatment for immunodeficiency.
NPS Pharmaceuticals walked away from an FDA panel meeting with a recommendation to approve its orphan drug, but a lukewarm reception and nagging safety concerns have investors fearing the worst.
The FDA last week issued two separate notices that it is looking for public comment on how the regulatory agency decides conditional approvals for new animal drugs as well as how it proceeds on giving its okay for combination drugs in medicated feeds.