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Regulatory

Latest Headlines

Latest Headlines

UPDATED: Vertex's Kalydeco scores FDA panel rec in R117H. Are bigger nods next?

Despite falling short of its primary endpoint in a trial to examine its effects in cystic fibrosis patients with the R117H mutation, Vertex's Kalydeco has scored an FDA advisory committee recommendation for approval in that population. And the way some see it, that's a sign of much, much bigger approvals to come.

FDA clears app to monitor brain health on the battlefield

Reaction time can be a sign of brain injuries that are common on the battlefield such as concussion, dementia, post-traumatic stress and depression, says product developer AnthroTronix.

UPDATED: Janssen recalls 13,500 bottles of Xarelto because of contamination

Johnson & Johnson's Janssen unit is recalling 13,500 bottles of its top-selling anticoagulant Xarelto because of microbial contamination.

Q&A: CMO says Covidien wants to engage parallel review process

FierceMedicalDevices caught up with Covidien Chief Medical Officer Dr. Michael Tarnoff at the annual AdvaMed conference in Chicago at the beginning of October. Tarnoff also performs minimally invasive and bariatric surgery part-time at Tufts Medical Center in Boston.

Novartis clears an FDA hurdle with its pioneering psoriasis treatment

A panel of FDA advisers voted unanimously in favor of approving Novartis' new anti-inflammatory treatment, an expected positive outcome for the company as it races to be first in line among what promises to be a crowded field.

FDA accepts app for Merck, Sanofi 6-in-1 combo vaccine

Sanofi's Pentacel, which protects children against 5 serious diseases, nabbed the No. 3 spot on the world's list of best-selling vaccines last year. Whether an investigational 6-in-1 combo from the French drugmaker and partner Merck can eventually match its success remains to be seen, but the pair is now one step closer to finding out.

FDA will start the new year with its Office of Quality in place

The Office of Pharmaceutical Quality will finally open Jan. 1, and the FDA's Janet Woodcock will serve as its first acting director.

FDA approves Dexcom smartphone-enabled device for continuous glucose monitor

Dexcom won FDA approval for its next-generation mobile communications device for diabetes monitoring, chalking up another regulatory win and furthering the company's R&D push.

Canada cuts Apotex a break on some banned drugs

More than three dozen drugs and APIs that were originally banned by health regulators in Canada will be allowed into the country because they are medically necessary.

A glitch in bioequivalence software puts trial results in doubt

Observed glitches with Thermo Fisher's popular drug development software have led to concerns that data used to win approvals may have been faulty, and the company is working alongside regulators to figure out just how widespread the issue may be.